Open AccessMineralocorticoid Receptor Antagonist Pretreatment to MINIMISE Reperfusion Injury After ST ‐Elevation Myocardial Infarction (The MINIMISE STEMI Trial): Rationale and Study Design
Author(s) -
Bulluck Heerajnarain,
Fröhlich Georg M.,
Mohdnazri Shah,
Gamma Reto A.,
Davies John R.,
Clesham Gerald J.,
Sayer Jeremy W.,
Aggarwal Rajesh K.,
Tang Kare H.,
Kelly Paul A.,
Jagathesan Rohan,
Kabir Alamgir,
Robinson Nicholas M.,
Sirker Alex,
Mathur Anthony,
Blackman Daniel J.,
Ariti Cono,
Krishnamurthy Arvindra,
White Steven K.,
Meier Pascal,
Moon James C.,
Greenwood John P.,
Hausenloy Derek J.
Publication year - 2015
Publication title -
clinical cardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.263
H-Index - 72
eISSN - 1932-8737
pISSN - 0160-9289
DOI - 10.1002/clc.22401
Subject(s) - medicine , myocardial infarction , cardiology , percutaneous coronary intervention , spironolactone , placebo , cardiac magnetic resonance imaging , mineralocorticoid receptor , adverse effect , reperfusion therapy , clinical endpoint , ventricular remodeling , randomized controlled trial , heart failure , magnetic resonance imaging , aldosterone , radiology , alternative medicine , pathology
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.