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1.

Background and Aims

Two weight gain prevention strategies, one targeting small changes to diet and physical activity and a second targeting large changes, significantly reduced weight gain in young adulthood. We examined whether weight gain prevention blunts genetic risk for body weight increase and/or high density lipoprotein cholesterol (HDL-C) lowering over two years.

Methods and Results

Participants were 524 male and female young adults (mean age = 28.2, SD = 4.3; mean BMI = 25.5, SD = 2.6). Obesity-related SNPs accounting for ≥ 0.04% of the variance were genotyped and combined into a genetic risk score. For HDL-C, SNPs within CETP, LIPC and FADS2 were genotyped. The obesity-related genetic risk score did not predict change in BMI independently or in interaction with treatment arm. However, consistent with the prior literature, each copy of the HDL-C risk, C, allele at CETP rs3764261 was associated with lower HDL-C at baseline. Moreover, significant interaction between SNP and treatment arm for change in HDL-C was observed (p = 0.02). In the control group, HDL-C change was dependent upon rs3764261 (p = 0.004) with C allele carriers showing a continued reduction in HDL-C. In contrast, within the two intervention groups, HDL-C increased on average with no differential effect of rs3764261 (p > 0.24). Notably, even among carriers of the CC genotype, small and large change arms were associated with increased HDL-C and the control arm a reduction (p = 0.013).

Conclusions

The C allele at CETP rs3764261 is a strong risk factor for low HDL-C in young adulthood but weight gain prevention may mitigate this risk.

Clinical Trial Registry number and website

clinicaltrials.gov Identifier: NCT01183689, https://clinicaltrials.gov/  相似文献   

2.

Background

Western guidelines recommend resection for hepatocellular carcinoma (HCC) in so-called ideal cirrhotic patients with a Barcelona Clinic Liver Cancer (BCLC) stage 0-A tumour. This study compares short-term outcomes following resection between patients defined as ideal and nonideal according to the BCLC guidelines.

Methods

This prospective single-centre open study (ClinicalTrials.govNCT02145013) included all cirrhotic patients with HCC referred for resection from 2014 to 2016. Mortality, morbidity, unresolved liver decompensation, and readmission were measured.

Results

The study population included 65 consecutive patients: 32 (49%) ideal and 33 (51%) nonideal. Ideal and nonideal groups did not differ in mortality (3% vs. 6%; p = 0.57), morbidity (53% vs. 73%; p = 0.10), or unresolved liver decompensation (6% vs. 15%; p = 0.23) at 90 days. The readmission rate was higher in the nonideal (21%) than in the ideal group (3%; p = 0.02).

Conclusion

Straying from the current guidelines for resection in a selected subset of nonideal patients doubled the number of resections performed for treating HCC, with satisfactory short-term outcomes. These results argue for the expansion of the acknowledged BCLC guidelines.  相似文献   

3.

Background and aims

Subclinical cardiac disease, like abnormal left ventricular (LV) geometry or left atrial (LA) dilatation, is common in obesity. Less is known about sex differences in the prevalence and type of subclinical cardiac disease in obesity.

Methods and results

Clinical and echocardiographic data from 581 women and men without established cardiovascular disease and body mass index (BMI) > 27.0 kg/m2 participating in the FAT associated CardiOvasculaR dysfunction (FATCOR) study was analyzed. LA dilatation was recognized as LA volume indexed for height2 ≥16.5 ml/m2 in women and ≥18.5 ml/m2 in men, and abnormal LV geometry as LV hypertrophy and/or increased relative wall thickness. On average, the participants were 48 years old, 60% women and mean BMI was 32.1 kg/m2. Overall, the prevalence of subclinical cardiac disease was higher in women than men (77% vs. 62%, p < 0.001). Women had a higher prevalence of LA dilatation than men (74% vs. 56%, p < 0.001), while men had a higher prevalence of abnormal LV geometry (30% vs. 21%, p = 0.011). After adjusting for confounders in multivariable logistic regression analysis, female sex was associated with a 2-fold higher risk of subclinical cardiac disease, in particular LA dilatation (confidence interval [CI] 1.67–3.49, p < 0.001), while male sex was associated with a 2-fold higher risk of abnormal LV geometry (CI 1.30–3.01, p = 0.001).

Conclusion

The majority of overweight and obese participants in the FATCOR study had subclinical cardiac disease, which may contribute to the impaired prognosis observed in obesity. Women had a higher prevalence of subclinical cardiac disease than men.

Clinical trial registration

URL: http://www.clinicaltrials.govNCT02805478.  相似文献   

4.

Background

Guidelines recommend the use of implanted cardioverter-defibrillators in patients with Brugada syndrome and induced ventricular tachyarrhythmias, but there is no evidence supporting it.

Objectives

This prospective registry study was designed to explore clinical and electrophysiological predictors of malignant ventricular tachyarrhythmia inducibility in Brugada syndrome.

Methods

A total of 191 consecutive selected patients with (group 1; n = 88) and without (group 2; n = 103) Brugada syndrome–related symptoms were prospectively enrolled in the registry. Patients underwent electrophysiological study and substrate mapping or ablation before and after ajmaline testing (1 mg/kg/5 min).

Results

Overall, before ajmaline testing, 53.4% of patients had ventricular tachyarrhythmia inducibility, which was more frequent in group 1 (65.9%) than in group 2 (42.7%; p < 0.001). Regardless of clinical presentation, larger substrates with more fragmented long-duration ventricular potentials were found in patients with inducible arrhythmias than in patients without inducible arrhythmias (p < 0.001). One extrastimulus was used in more extensive substrates (median 13 cm2; p < 0.001), and ventricular fibrillation was the more frequently induced rhythm (p < 0.001). After ajmaline, patients without arrhythmia inducibility had arrhythmia inducibility without a difference in substrate characteristics between the 2 groups. The substrate size was the only independent predictor of inducibility (odds ratio: 4.51; 95% confidence interval: 2.51 to 8.09; p < 0.001). A substrate size of 4 cm2 best identified patients with inducible arrhythmias (area under the curve: 0.98; p < 0.001). Substrate ablation prevented ventricular tachyarrhythmia reinducibility.

Conclusions

In Brugada syndrome dynamic substrate variability represents the pathophysiological basis of lethal ventricular tachyarrhythmias. Substrate size is independently associated with arrhythmia inducibility, and its determination after ajmaline identifies high-risk patients missed by clinical criteria. Substrate ablation is associated with electrocardiogram normalization and not arrhythmia reinducibility. (Epicardial Ablation in Brugada Syndrome [BRUGADA_I]; NCT02641431; Epicardial Ablation in Brugada Syndrome: An Extension Study of 200 BrS Patients; NCT03106701)  相似文献   

5.

Objectives

This study aimed to investigate the 5-year clinical follow-up of the HYBRID (Hybrid Revascularization for Multivessel Coronary Artery Disease) trial.

Background

The HYBRID trial, the only randomized study involving thorough analysis of outcome after the 2 procedures, suggested that hybrid coronary revascularization (HCR) is feasible in selected patients with multivessel coronary disease referred for conventional coronary artery bypass grafting (CABG). There are currently no long-term outcome data from randomized trials in this setting.

Methods

A total of 200 patients with multivessel coronary disease referred for conventional surgical revascularization were randomly assigned to undergo HCR or CABG. The primary endpoint was the occurrence of all-cause mortality at 5 years.

Results

Nine patients (4 in HCR and 5 in CABG group) were lost to the 5-year follow-up. Finally, 191 patients (94 in HCR and 97 in CABG group) formed the basis of this study. The groups were well balanced in terms of pre-procedural characteristics. All-cause mortality at 5-year follow-up was similar in the 2 groups (6.4% for HCR vs. 9.2% for CABG; p = 0.69). The rates of myocardial infarction (4.3% vs. 7.2%; p = 0.30), repeat revascularization (37.2% vs. 45.4%; p = 0.38), stroke (2.1% vs. 4.1%; p = 0.35), and major adverse cardiac and cerebrovascular events (45.2% vs. 53.4%; p = 0.39) were also similar in the 2 groups.

Conclusions

HCR has similar 5-year all-cause mortality when compared with conventional coronary bypass grafting (Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease; NCT01035567)  相似文献   

6.

Background

Early outcomes of patients in the PRAGUE-18 (Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction) study did not find any significant differences between 2 potent P2Y12 inhibitors.

Objectives

The 1-year follow-up of the PRAGUE-18 study focused on: 1) a comparison of efficacy and safety between prasugrel and ticagrelor; and 2) the risk of major ischemic events related to an economically motivated post-discharge switch to clopidogrel.

Methods

A total of 1,230 patients with acute myocardial infarction (MI) treated with primary percutaneous coronary intervention were randomized to prasugrel or ticagrelor with an intended treatment duration of 12 months. The combined endpoint was cardiovascular death, MI, or stroke at 1 year. Because patients had to cover the costs of study medication after hospital discharge, some patients decided to switch to clopidogrel.

Results

The endpoint occurred in 6.6% of prasugrel patients and in 5.7% of ticagrelor patients (hazard ratio: 1.167; 95% confidence interval: 0.742 to 1.835; p = 0.503). No significant differences were found in: cardiovascular death (3.3% vs. 3.0%; p = 0.769), MI (3.0% vs. 2.5%; p = 0.611), stroke (1.1% vs. 0.7%; p = 0.423), all-cause death (4.7% vs. 4.2%; p = 0.654), definite stent thrombosis (1.1% vs. 1.5%; p = 0.535), all bleeding (10.9% vs. 11.1%; p = 0.999), and TIMI (Thrombolysis In Myocardial Infarction) major bleeding (0.9% vs. 0.7%; p = 0.754). The percentage of patients who switched to clopidogrel for economic reasons was 34.1% (n = 216) for prasugrel and 44.4% (n = 265) for ticagrelor (p = 0.003). Patients who were economically motivated to switch to clopidogrel had (compared with patients who continued the study medications) a lower risk of major cardiovascular events; however, they also had lower ischemic risk.

Conclusions

Prasugrel and ticagrelor are similarly effective during the first year after MI. Economically motivated early post-discharge switches to clopidogrel were not associated with an increased risk of ischemic events. (Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction [PRAGUE-18]; NCT02808767)  相似文献   

7.

Objectives

The aims of the study were to assess the prognostic significance of cardiac magnetic resonance myocardial feature tracking (CMR-FT) in a large multicenter study and to evaluate the most potent CMR-FT predictor of hard clinical events following myocardial infarction (MI).

Background

CMR-FT is a new method that allows accurate assessment of global and regional circumferential, radial, and longitudinal myocardial strain. The prognostic value of CMR-FT in patients with reperfused MI is unknown.

Methods

The study included 1,235 MI patients (n = 795 with ST-segment elevation MI and 440 with non–ST-elevation MI) at 15 centers. All patients were reperfused by primary percutaneous coronary intervention. Central core laboratory–masked analyses were performed to determine left ventricular (LV) circumferential, radial, and longitudinal strain. The primary clinical endpoint of the study was the occurrence of major adverse cardiac events within 12 months after infarction.

Results

Patients with cardiovascular events had significantly impaired CMR-FT strain values (p < 0.001 for all). Global longitudinal strain was identified as the strongest CMR-FT parameter of future cardiovascular events and emerged as an independent predictor of poor prognosis following MI even after adjustment for established prognostic markers. Global longitudinal strain provided an incremental prognostic value for all-cause mortality above LV ejection fraction (c-index increase from 0.65 to 0.73; p = 0.04) and infarct size (c-index increase from 0.60 to 0.78; p = 0.002).

Conclusions

CMR-FT is a superior measure of LV function and performance early after reperfused MI with incremental prognostic value for mortality over and above LV ejection fraction and infarct size. (Abciximab i.v. Versus i.c. in ST-segment elevation Myocardial Infarction [AIDA STEMI]; NCT00712101; Thrombus Aspiration in ThrOmbus Containing culpRIT Lesions in Non-ST-Elevation Myocardial Infarction [TATORT-NSTEMI]; NCT01612312)  相似文献   

8.

Background

The burden oral anticoagulation is a limitation of mechanical valve prostheses.

Objectives

The aim of this study was to test whether patients could be safely managed with dual-antiplatelet therapy (DAPT) (aspirin 325 mg and clopidogrel 75 mg) or lower warfarin after On-X mechanical aortic valve replacement (mAVR).

Methods

PROACT (Prospective Randomized On-X Anticoagulation Trial) (n = 576) is a multicenter (41 sites) noninferiority trial. From June 2006 through February 2014, 201 patients ≥18 years of age without thromboembolic risk factors undergoing mAVR were randomized to receive DAPT (n = 99) or standard warfarin plus aspirin (n = 102) 3 months after mAVR (low-risk arm). From June 2006 through October 2009, 375 patients with 1 or more thromboembolic risk factors were also randomized to lower intensity warfarin plus aspirin (international normalized ratio 1.5 to 2.0; n = 185) or standard warfarin plus aspirin (international normalized ratio 2.0 to 3.0; n = 190) 3 months after mAVR (high-risk arm).

Results

The low-risk arm was terminated for excess cerebral thromboembolic events (3.12% per patient-year vs. 0.29% per patient-year, p = 0.02) in the DAPT group at up to 8.8-year follow-up (631.6 patient-years), with no differences in bleeding or all-cause mortality. High-risk arm patients experienced significantly lower major (1.59% per patient-year vs. 3.94% per patient-year, p = 0.002) and minor (1.27% per patient-year vs. 3.49% per patient-year, p = 0.002) bleeding up to 8.7-year follow-up (2,035.2 patient-years), with no differences in thromboembolism (0.42% per patient-year vs. 0.09% per patient-year, p = 0.20) and all-cause mortality.

Conclusions

DAPT was associated with higher rates of thromboembolism and valve thrombosis compared with control in the low-risk arm. International normalized ratios were safely maintained at 1.5 to 2.0 in high-risk patients, without differences in mortality or thromboembolic complications. (Randomized On-X Anticoagulation Trial [PROACT]; NCT00291525)  相似文献   

9.

Objectives

The authors sought to clarify how intravascular ultrasound (IVUS) and optical coherence tomography affect percutaneous coronary intervention (PCI) with current-generation drug-eluting stents in a pre-specified substudy of the OPINION (OPtical frequency domain imaging versus INtravascular ultrasound in percutaneous coronary interventiON) trial, a multicenter, prospective, randomized, noninferiority trial comparing optical frequency domain imaging (OFDI)-guided PCI with IVUS-guided PCI.

Background

The impact of these 2 imaging modalities in guiding PCI remains unknown.

Methods

Of 829 patients enrolled in the OPINION trial, 106 were included in the present imaging substudy. Their PCI was guided by either IVUS or OFDI, but all patients were imaged by both modalities after PCI and by OFDI at 8 months. Angiographic, OFDI, and IVUS images were analyzed by independent core laboratories, and statistical analysis was done independently by a dedicated institution.

Results

A total of 103 patients underwent either OFDI-guided (n = 54) or IVUS-guided (n = 49) PCI. Immediately after PCI, OFDI-guided PCI was associated with a smaller trend of minimum stent area (5.28 ± 1.65 mm2 vs. 6.12 ± 2.34 mm2; p = 0.088), fewer proximal stent-edge hematomas (p = 0.04), and fewer irregular protrusions (p = 0.014) than IVUS-guided PCI. At 8 months, the neointima area tended to be smaller in the OFDI-guided PCI group than in the IVUS-guided PCI group (0.56 ± 0.30 mm2 vs. 0.80 ± 0.65 mm2; p = 0.057), although the percentage of uncovered struts was significantly higher in the OFDI-guided PCI group than in the IVUS-guided PCI group (6.97 ± 7.03% vs. 4.67 ± 6.43%; p = 0.039). The minimum lumen area was comparable in both groups (p = 0.18).

Conclusions

There were several differences in local findings between OFDI- and IVUS-guided PCI as expected given the different protocols for stent sizing in the 2 groups. The minimum lumen area at the 8-month follow-up was comparable, suggesting that OFDI- and IVUS-guided PCI are similarly feasible using the current-generation drug-eluting stents. (OPtical frequency domain imaging versus INtravascular ultrasound in percutaneous coronary interventiON; NCT01873222)  相似文献   

10.

Background

There is little evidence regarding the efficacy of interventions to prepare adolescents with congenital heart disease (CHD) to enter adult care.

Objectives

The goal of this study was to evaluate the impact of a nurse-led transition intervention on lapses between pediatric and adult care.

Methods

A cluster randomized clinical trial was conducted of a nurse-led transition intervention for 16- to 17-year-olds with moderate or complex CHD versus usual care. The intervention group received two 1-h individualized sessions targeting CHD education and self-management skills. The primary outcome was excess time to adult CHD care, defined as the interval between the final pediatric and first adult cardiology appointments, minus the recommended time interval, analyzed by using Cox proportional hazards regression accounting for clustering. Secondary outcomes included scores on the MyHeart CHD knowledge survey and the Transition Readiness Assessment Questionnaire.

Results

A total of 121 participants were randomized to receive the intervention (n = 58) or usual care (n = 63). At the recommended time of first adult appointment (excess time = 0), intervention participants were 1.8 times more likely to have their appointment within 1 month (95% confidence interval: 1.1 to 2.9; Cox regression, p = 0.018). This hazard increased with time; at an excess time of 6 months, intervention participants were 3.0 times more likely to have an appointment within 1 month (95% confidence interval: 1.1 to 8.3). The intervention group had higher scores at 1, 6, 12, and 18 months on the MyHeart knowledge survey (mixed models, p < 0.001) and the Transition Readiness Assessment Questionnaire self-management index (mixed models, p = 0.032).

Conclusions

A nurse-led intervention reduced the likelihood of a delay in adult CHD care and improved CHD knowledge and self-management skills. (Congenital Heart Adolescents Participating in Transition Evaluation Research [CHAPTER 2]; NCT01723332)  相似文献   

11.

Background

Anthracycline (ANT) chemotherapy is associated with cardiotoxicity. Prevention with β-blockers remains controversial.

Objectives

This prospective, randomized, double-blind, placebo-controlled study sought to evaluate the role of carvedilol in preventing ANT cardiotoxicity.

Methods

The authors randomized 200 patients with HER2-negative breast cancer tumor status and normal left ventricular ejection fraction (LVEF) referred for ANT (240 mg/m2) to receive carvedilol or placebo until chemotherapy completion. The primary endpoint was prevention of a ≥10% reduction in LVEF at 6 months. Secondary outcomes were effects of carvedilol on troponin I, B-type natriuretic peptide, and diastolic dysfunction.

Results

Primary endpoint occurred in 14 patients (14.5%) in the carvedilol group and 13 patients (13.5%) in the placebo group (p = 1.0). No differences in changes of LVEF or B-type natriuretic peptide were noted between groups. A significant difference existed between groups in troponin I levels over time, with lower levels in the carvedilol group (p = 0.003). Additionally, a lower incidence of diastolic dysfunction was noted in the carvedilol group (p = 0.039). A nonsignificant trend toward a less-pronounced increase in LV end-diastolic diameter during the follow-up was noted in the carvedilol group (44.1 ± 3.64 mm to 45.2 ± 3.2 mm vs. 44.9 ± 3.6 mm to 46.4 ± 4.0 mm; p = 0.057).

Conclusions

In this largest clinical trial of β-blockers for prevention of cardiotoxicity under contemporary ANT dosage, the authors noted a 13.5% to 14.5% incidence of cardiotoxicity. In this scenario, carvedilol had no impact on the incidence of early onset of LVEF reduction. However, the use of carvedilol resulted in a significant reduction in troponin levels and diastolic dysfunction. (Carvedilol Effect in Preventing Chemotherapy-Induced Cardiotoxicity [CECCY]; NCT01724450)  相似文献   

12.

Objectives

This study sought to compare early emergency department (ED) use of coronary computed tomography angiography (CTA) and stress echocardiography (SE) head-to-head.

Background

Coronary CTA has been promoted as the early ED chest pain triage imaging method of choice, whereas SE is often overlooked in this setting and involves no ionizing radiation.

Methods

The authors randomized 400 consecutive low- to intermediate-risk ED acute chest pain patients without known coronary artery disease and a negative initial serum troponin level to immediate coronary CTA (n = 201) or SE (n = 199). The primary endpoint was hospitalization rate. Secondary endpoints were ED and hospital length of stay. Safety endpoints included cardiovascular events and radiation exposure.

Results

Mean patient age was 55 years, with 43% women and predominantly ethnic minorities (46% Hispanics, 32% African Americans). Thirty-nine coronary CTA patients (19%) and 22 SE patients (11%) were hospitalized at presentation (difference 8%; 95% confidence interval: 1% to 15%; p = 0.026). Median ED length of stay for discharged patients was 5.4 h (interquartile range [IQR]: 4.2 to 6.4 h) for coronary CTA and 4.7 h (IQR: 3.5 to 6.0 h) for SE (p < 0.001). Median hospital length of stay was 58 h (IQR: 50 to 102 h) for coronary CTA and 34 h (IQR: 31 to 54 h) for SE (p = 0.002). There were 11 and 7 major adverse cardiovascular events for coronary CTA and SE, respectively (p = 0.47), over a median 24 months of follow-up. Median/mean complete initial work-up radiation exposure was 6.5/7.7 mSv for coronary CTA and 0/0.96 mSv for SE (p < 0.001).

Conclusions

The use of SE resulted in the hospitalization of a smaller proportion of patients with a shorter length of stay than coronary CTA and was safe. SE should be considered an appropriate option for ED chest pain triage (Stress Echocardiography and Heart Computed Tomography [CT] Scan in Emergency Department Patients With Chest Pain; NCT01384448)  相似文献   

13.

Background

Recent reports showing the favorable role of patent foramen ovale (PFO) closure in patients with cryptogenic stroke have raised the issue of selecting optimal candidates.

Objectives

This study, DEFENSE-PFO (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale), evaluated whether the benefits of PFO closure can be determined on the basis of the morphologic characteristics of the PFO, as evaluated by transesophageal echocardiography.

Methods

Patients with cryptogenic stroke and high-risk PFO were divided between a transcatheter PFO closure and a medication-only group. High-risk PFO included PFO with atrial septal aneurysm, hypermobility (phasic septal excursion into either atrium ≥10 mm), or PFO size (maximum separation of the septum primum from the secundum) ≥2 mm. The primary endpoint was a composite of stroke, vascular death, or Thrombolysis In Myocardial Infarction–defined major bleeding during 2 years of follow-up.

Results

From September 2011 until October 2017, 120 patients (mean age: 51.8 years) underwent randomization. PFO size, frequency of septal aneurysm (13.3% vs. 8.3%; p = 0.56), and hypermobility (45.0% vs. 46.7%; p > 0.99) were similar between the groups. All PFO closures were successful. The primary endpoint occurred exclusively in the medication-only group (6 of 60 patients; 2-year event rate: 12.9% [log-rank p = 0.013]; 2-year rate of ischemic stroke: 10.5% [p = 0.023]). The events in the medication-only group included ischemic stroke (n = 5), cerebral hemorrhage (n = 1), Thrombolysis In Myocardial Infarction–defined major bleeding (n = 2), and transient ischemic attack (n = 1). Nonfatal procedural complications included development of atrial fibrillation (n = 2), pericardial effusion (n = 1), and pseudoaneurysm (n = 1).

Conclusions

PFO closure in patients with high-risk PFO characteristics resulted in a lower rate of the primary endpoint as well as stroke recurrence. (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale [DEFENSE-PFO]; NCT01550588)  相似文献   

14.

Background and aims

High-protein (HP) diets have shown benefits in cardiometabolic markers such as insulin or triglycerides but the responsible mechanisms are not known. We aimed to assess the effect of three energy-restricted diets with different protein contents (20%, 27%, and 35%; ~80% coming from animal source) on plasma adipokine concentration and its association with changes in cardiometabolic markers.

Methods

Seventy-six women (BMI 32.8 ± 2.93) were randomized to one of three calorie-reduced diets, with protein, 20%, 27%, or 35%; carbohydrates, 50%, 43%, or 35%; and fat, 30%, for 3 months. Plasma adipokine (leptin, resistin, adiponectin, and retinol-binding protein 4; RBP4) levels were assessed.

Results

After 3 months, leptin concentration decreased in all groups without differences among them, while resistin levels remained unchanged. Adiponectin concentration heterogeneously changed in all groups (P for trend = 0.165) and resistin concentration did not significantly change. RPB4 significantly decreased by ?17.5% (?31.7, ?3.22) in 35%-protein diet (P for trend = 0.024 among diets). Triglycerides improved in women following the 35%-protein diet regardless of weight loss; RBP4 variation significantly influenced triglyceride concentration change by 24.9% and 25.9% when comparing 27%- and 35%- with 20%-protein diet, respectively.

Conclusions

A 35%-protein diet induced a decrease in RBP4 regardless of weight loss, which was directly associated with triglyceride concentration improvement. These findings suggest that HP diets improve the cardiometabolic profile, at least in part, through changes in adipokine secretion. Whether this beneficial effect of HP diet is due to improvements in hepatic or adipose tissue functionality should be elucidated.

Clinical trial registration

The clinical trial has been registered in ClinicalTrials.gov (Identifier: NCT02160496).  相似文献   

15.

Background and Aims

High-cholesterol and high-fat diets alter biochemical composition and anti-oxidant properties of high-density lipoproteins (HDL) in animals. Whether this occurs in humans is unknown. Therefore, we examined the effect of a short-term elevation in dietary cholesterol and fat intake on HDL composition in healthy subjects.

Methods and Results

In a randomized, crossover clinical trial, 14 healthy young volunteers followed a 14-day low-cholesterol/low-fat diet (LChF) and a 14-day isocaloric high-cholesterol/high-fat diet (HChF) in a random order. After each diet, we measured HDL concentrations of hydroxyeicosatetraenoic acids (HETE), hydroxyoctadecadienoic acids (HODE), and haptoglobin, as well as serum amyloid A (SAA) and paroxonase-1 activity (PON-1). HDL concentrations of 15-HETE (+254%, p = 0.002), 5-HETE (+116%, p = 0.004), 13-HODE (+102%, p = 0.049), and SAA levels (+75%, p = 0.007) were significantly higher after the HChF than after the LChF. Furthermore, haptoglobin was marginally increased (+32%, p = 0.091) while PON-1 activity was unaffected (?16%, p = 0.366) by the HChF.

Conclusion

In healthy subjects, a short-term elevation in dietary cholesterol and fat intake increases HDL lipid hydroperoxide content (15-HETE, 5-HETE, 13-HODE) and SAA levels, which are key features of dysfunctional HDL. This is the first study showing that a physiologic manipulation of dietary cholesterol and fat intake affects HDL lipidome and proteome in healthy subjects independently of weight changes.

Clinical Trial Registration

NCT02549144.  相似文献   

16.

Background

Neoadjuvant treatment of colorectal liver metastases has become increasingly common, and while effective, often renders small metastases difficult to visualize on intraoperative US. The objective of this study was to determine the utility of a 3D image-guidance system in patients with intraoperative sonographically-occult CRLM.

Methods

50 patients with at least one CRLM ≤ 1.5 cm were enrolled in this prospective trial of an FDA-approved Explorer image-guidance system. If the tumor(s) seen on preoperative imaging were not identified with intraoperative US, Explorer was used to target the US examination to the involved area for a more focused assessment. The primary endpoint was the proportion of cases with sonographically-occult metastases identified using Explorer.

Results

Forty-eight patients with preoperative scans within eight weeks of surgery were included for analysis. Forty-six patients were treated with preoperative chemotherapy (median 4 months, range 2–24 months). Overall, 22 sonographically-occult tumors in 14 patients were interrogated by Explorer, of which 15 tumors in 10 patients were located with image-guidance assistance. The only difference between patients with tumors not identified on US and those who did was the number of tumors (median 3 vs. 2, p = 0.018).

Conclusion

3D image-guidance can assist in identifying small CRLM, particularly after treatment with chemotherapy.

Trial registration

ClinicalTrials.gov, NCT02806037, https://clinicaltrials.gov/ct2/show/NCT02806037.  相似文献   

17.

Objectives

The authors sought to evaluate the safety and effectiveness of the NeoVas bioresorbable scaffold (BRS) compared with metallic drug-eluting stents.

Background

BRS have the potential to improve very late outcomes compared with metallic drug-eluting stents, but some BRS have been associated with increased rates of device thrombosis before complete bioresorption. NeoVas is a new poly-l-lactic acid BRS that elutes sirolimus from a poly-D, l-lactide coating.

Methods

Eligible patients with a single de novo native coronary artery lesion with a reference vessel diameter 2.5 to 3.75 mm and a lesion length ≤20 mm were randomized 1:1 to NeoVas BRS versus cobalt-chromium everolimus-eluting stents (CoCr-EES). Angiographic follow-up was performed in all patients at 1 year. The primary endpoint was angiographic in-segment late loss (LL), and the major secondary endpoint was the rate of angina. Baseline and follow-up optical coherence tomography and fractional flow reserve were performed in a pre-specified subgroup of patients.

Results

The authors randomized 560 patients at 32 centers to treatment with NeoVas (n = 278) versus CoCr-EES (n = 282). One-year in-segment LL with NeoVas and CoCr-EES were 0.14 ± 0.36 mm versus 0.11 ± 0.34 mm (difference 0.03 mm; upper 1-sided 97.5% confidence interval 0.09 mm; pnoninferiority < 0.0001; psuperiority = 0.36). Clinical outcomes at 1 year were similar in the 2 groups, as were the rates of recurrent angina (27.9% vs. 32.1%; p = 0.26). Optical coherence tomography at 1 year demonstrated a higher proportion of covered struts (98.7% vs. 96.2%; p < 0.001), less strut malapposition (0% vs. 0.6%; p <0.001), and a smaller minimal lumen area (4.71 ± 1.64 vs. 6.00 ± 2.15 mm2; p < 0.001) with NeoVas compared with CoCr-EES respectively, with nonsignificant differences in fractional flow reserve (0.89 ± 0.08 vs. 0.91 ± 0.06; p = 0.07).

Conclusions

The NeoVas BRS was noninferior to CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL, and resulted in comparable 1-year clinical outcomes, including recurrent angina. (NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial; NCT02305485)  相似文献   

18.

Background

Data regarding neoatherosclerosis after everolimus-eluting bioresorbable vascular scaffold (BVS) (ABSORB BVS Rev. 1.1, Abbott Vascular, Santa Clara, California) implantation are limited.

Objectives

This study investigated the findings of neoatherosclerosis at 5 years after BVS 1.1 implantation by using multi-imaging modalities, including optical coherence tomography (OCT).

Methods

Patients included in the ABSORB EXTEND (ABSORB EXTEND Clinical Investigation) trial at Shonan Kamakura General Hospital underwent OCT at baseline after the index procedure and at 1 and 5 years. Intimal plaque distributions in the in-scaffold and out-scaffold segments were analyzed.

Results

Twenty patients (22 lesions) with stable angina pectoris were enrolled. The median follow-up duration was 67 months (interquartile range: 65 to 69 months), and the mean age was 69 ± 8 years. Patients with diabetes mellitus (25%) were included. Based on the baseline angiogram, 10 (46%) lesions were type B2/C lesions. At 1 and 5 years of follow-up, significant differences in the prevalence of in-scaffold lipid-laden neointima (17% vs. 61%; p = 0.04), calcification (28% vs. 94%; p < 0.01), neovascularization (6% vs. 78%; p < 0.01), and thin-cap fibroatheroma (0% vs. 22%; p = 0.02) were found. In the out-scaffold segments, no significant difference in the plaque prevalence between 1 and 5 years was noted.

Conclusions

The occurrence and progression of in-scaffold neoatherosclerosis with luminal narrowing was observed at 5 years after BVS 1.1 implantation. The small size of the current study warrants confirmation in larger study. (ABSORB EXTEND Clinical Investigation [ABSORB EXTEND]; NCT01023789)  相似文献   

19.

Objectives

This study sought to determine the incidence and prognostic significance of persistent iron in patients post–ST-segment elevation myocardial infarction (STEMI).

Background

The clinical significance of persistent iron within the infarct core after STEMI complicated by acute myocardial hemorrhage is poorly understood.

Methods

Patients who sustained an acute STEMI were enrolled in a cohort study (BHF MR-MI [Detection and Significance of Heart Injury in ST Elevation Myocardial Infarction]). Cardiac magnetic resonance imaging including T2* (observed time constant for the decay of transverse magnetization seen with gradient-echo sequences) mapping was performed at 2 days and 6 months post-STEMI. Myocardial hemorrhage or iron was defined as a hypointense infarct core with T2* signal <20 ms.

Results

A total of 203 patients (age 57 ± 11 years, n = 158 [78%] male) had evaluable T2* maps at 2 days and 6 months post-STEMI; 74 (36%) patients had myocardial hemorrhage at baseline, and 44 (59%) of these patients had persistent iron at 6 months. Clinical associates of persistent iron included heart rate (p = 0.009), the absence of a history of hypertension (p = 0.017), and infarct size (p = 0.028). The presence of persistent iron was associated with worsening left ventricular (LV) end-diastolic volume (regression coefficient: 21.10; 95% confidence interval [CI]: 10.92 to 31.27; p < 0.001) and worsening LV ejection fraction (regression coefficient: ?6.47; 95% CI: ?9.22 to ?3.72; p < 0.001). Persistent iron was associated with the subsequent occurrence of all-cause death or heart failure (hazard ratio: 3.91; 95% CI: 1.37 to 11.14; p = 0.011) and major adverse cardiac events (hazard ratio: 3.24; 95% CI: 1.09 to 9.64; p = 0.035) (median follow-up duration 1,457 days [range 233 to 1,734 days]).

Conclusions

Persistent iron at 6 months post-STEMI is associated with worse LV and longer-term health outcomes. (Detection and Significance of Heart Injury in ST Elevation Myocardial Infarction [BHF MR-MI]; NCT02072850)  相似文献   

20.

Background

Cross correlation analysis (CCA) using tissue Doppler imaging has been shown to be associated with outcome after cardiac resynchronization therapy (CRT) in patients with heart failure (HF) with wide QRS. However, its significance in patients with narrow QRS treated with CRT is unknown.

Objectives

The aim of the current study was to investigate the association of mechanical activation delay by CCA with study outcome in patients with HF enrolled in the EchoCRT trial.

Methods

Baseline CCA could be performed from tissue Doppler imaging in the apical views in 807 of 809 (99.7%) enrolled patients, and 6-month follow-up could be performed in 610 of 635 (96%) patients with available echocardiograms. Patients with a pre-specified maximal activation delay ≥35 ms were considered to have significant delay. The study outcome was HF hospitalization or death.

Results

Of 807 patients, 375 (46%) did not have delayed mechanical activation at baseline by CCA. Patients without delayed mechanical activation who were randomized to CRT-On compared with CRT-Off had an increased risk of poor outcome (hazard ratio: 1.70; 95% confidence interval: 1.13 to 2.55; p = 0.01) with a significant interaction term (p = 0.04) between delayed mechanical activation and device randomization for the endpoint. Among patients with paired baseline and follow-up data with no events before 6-month follow-up (n = 541), new-onset delayed mechanical activation in the CRT-On group showed a significant increase in unfavorable events (hazard ratio: 3.73; 95% confidence interval: 1.15 to 12.14; p = 0.03).

Conclusions

In the EchoCRT population, absence of delayed mechanical activation by CCA was significantly associated with poor outcomes, possibly due to the onset of new delayed mechanical activation with CRT pacing. (Echocardiography Guided Cardiac Resynchronization Therapy [EchoCRT] Trial; NCT00683696)  相似文献   

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