MINIMISE STEMI trial
Research type
Research Study
Full title
MINeralocorticoid receptor antagonist pretreatment to MINIMISE reperfusion injury after ST-Elevation Myocardial Infarction(STEMI).
IRAS ID
124045
Contact name
Derek Hausenloy
Contact email
Sponsor organisation
University College London (UCL)
Eudract number
2013-001069-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 29 days
Research summary
Heart attacks, or myocardial infarcts, are a major cause of death and disability in the UK. Immediate unblocking of the obstructed heart vessel with a balloon catheter and implantation of a mesh scaffold (stent) in heart centers is warranted in these patients. Morbidity and mortality in this patient group is related to the infarct size. Therefore, there is a need to discover novel therapeutic agents which reduce myocardial infarct size and preserve the contractile heart function.
Large trials involving several thousand patients have demonstrated a survival benefit in patients with impaired heart function due to a heart attack, who received a mineralo-corticoid receptor antagonist (MRA, drug name: spironolactone). In these trials patients received the drug late, 3-14 days after the heart attack.
Our proposal is to investigate whether MRA therapy administered intravenously prior to unblocking an occluded heart vessel, can reduce infarct size and as such can prevent long term sequelae of heart attacks.
150 patients admitted to 3 tertiary care hospitals (Heart Hospital London, London Chest, Essex Cardiothoracic Center Basildon) for heart attack will be randomly assigned to receive MRA treatment or placebo. The first dose of the MRA will be applied intravenously immediately in the catheter suite, even befor re-opening of the occluded vessel. From the second day on, patients will be prescribed oral MRA treatment, as a pill, for a total of three months. Before hospital discharge and after three months, a magnetic resonance image (MRI) of the heart will accurately investigate the evolution of infarct (scar) size and the contractile heart function and compare the group of patients who received the MRA drug versus the placebo control group.
This study will give first evidence, if very early MRA treatment improves heart function and should be used as early as possible for treatment of patients after a heart attack.REC name
London - South East Research Ethics Committee
REC reference
13/LO/0669
Date of REC Opinion
4 Jun 2013
REC opinion
Further Information Favourable Opinion