Stratified Medicine of Eplerenone in Acute MI/Injury (StratMed-MINOCA)
Status:
Not yet recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
Summary
Patients with heart attack or heart injury are tested (angiogram) for blockages in their
arteries. Many patients develop heart problems caused by damage to small (microvascular)
blood vessels. These issues are also relevant to patients with COVID-19. Eplerenone reduces
blood vessel injury and is used to treat heart failure.
AIM: to test the use of eplerenone in patients with heart attack/heart injury who have small
vessel disease, including patients with COVID-19
Patients referred to the Golden Jubilee hospital with a suspected heart attack heart / injury
will be invited to participate into a registry-based clinical trial. Screening, enrolment and
verbal, informed consent will be obtained during the angiogram then written consent on the
ward. Small vessel disease will be assessed using a 'diagnostic' guidewire during the
standard angiogram. People with small vessel problems will be allocated to a clinical trial
of usual care or eplerenone.
Patients will be allocated into one of the 3 groups:
- Group 1: Patients with normal small vessel function. No eplerenone
- Group 2: Small vessels abnormal. Usual care, no eplerenone.
- Group 3: Small vessels abnormal. Eplerenone tablets.
The primary outcome for the trial will be reduced heart injury (biomarkers) in patients with
microvascular disease. We will also test heart function (MRI scan) at enrolment and at six
months. All patients (Groups 1, 2 and 3) will have an angiogram. Standard blood tests will be
collected during the hospital stay, and then again at 1 and 6 months. Other outcomes include
questionnaires (health status). We will gather information on longer-term health outcomes
(hospitalisation, death) using confidential electronic record linkage. We will ask for
permission to store blood samples for future research.
The research will improve scientific knowlege about eplerenone therapy in this patient group.
The study will create a repository of clinical samples and images which will provide vital
data for studies of COVID-19.