Mineralocorticoid Receptor Antagonist Pretreatment to MINIMISE Reperfusion Injury After ST‐Elevation Myocardial Infarction (The MINIMISE STEMI Trial): Rationale and Study Design |
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| Authors: | Heerajnarain Bulluck MBBS Georg M. Fröhlich MD Shah Mohdnazri MBBS Reto A. Gamma FRCP John R. Davies PhD Gerald J. Clesham MD Jeremy W. Sayer MD Rajesh K. Aggarwal MD Kare H. Tang FRCP Paul A. Kelly MD Rohan Jagathesan MD Alamgir Kabir PhD Nicholas M. Robinson MD Alex Sirker PhD Anthony Mathur PhD Daniel J. Blackman MD Cono Ariti MSc Arvindra Krishnamurthy MBBS Steven K. White MBBS Pascal Meier MD James C. Moon MD John P. Greenwood PhD Derek J. Hausenloy MDPhD |
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| Affiliation: | 1. Department of Cardiology, Heart Hospital, London, United Kingdom;2. National Institute of Health Research, University College London Hospitals Biomedical Research Centre, London, United Kingdom;3. Hatter Cardiovascular Institute, Institute of Cardiovascular Science, London, United Kingdom;4. Department of Cardiology, Leeds General Infirmary, Leeds, United Kingdom;5. Department of Cardiology, Essex Cardiothoracic Center, Nethermayne, Basildon, United Kingdom;6. London Department of Cardiology, Chest Hospital, London, United Kingdom;7. Nuffield Health Trust, London, United Kingdom;8. London School of Hygiene and Tropical Medicine, London, United Kingdom;9. Cardiovascular and Metabolic Disorders Program, Duke‐National University of Singapore, Singapore;10. National Heart Research Institute Singapore, National Heart Centre Singapore, Singapore |
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| Abstract: | Novel therapies capable of reducing myocardial infarct (MI) size when administered prior to reperfusion are required to prevent the onset of heart failure in ST‐segment elevation myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PPCI). Experimental animal studies have demonstrated that mineralocorticoid receptor antagonist (MRA) therapy administered prior to reperfusion can reduce MI size, and MRA therapy prevents adverse left ventricular (LV) remodeling in post‐MI patients with LV impairment. With these 2 benefits in mind, we hypothesize that initiating MRA therapy prior to PPCI, followed by 3 months of oral MRA therapy, will reduce MI size and prevent adverse LV remodeling in STEMI patients. The MINIMISE‐STEMI trial is a prospective, randomized, double‐blind, placebo‐controlled trial that will recruit 150 STEMI patients from four centers in the United Kingdom. Patients will be randomized to receive either an intravenous bolus of MRA therapy (potassium canrenoate 200 mg) or matching placebo prior to PPCI, followed by oral spironolactone 50 mg once daily or matching placebo for 3 months. A cardiac magnetic resonance imaging scan will be performed within 1 week of PPCI and repeated at 3 months to assess MI size and LV remodeling. Enzymatic MI size will be estimated by the 48‐hour area‐under‐the‐curve serum cardiac enzymes. The primary endpoint of the study will be MI size on the 3‐month cardiac magnetic resonance imaging scan. The MINIMISE STEMI trial will investigate whether early MRA therapy, initiated prior to reperfusion, can reduce MI size and prevent adverse post‐MI LV remodeling. |
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