Prognostic Significance of CMR-Confirmed Infarct in MINOCA Patients from Sweden and Australia (SWEET)

University of Adelaide

Status: Completed

Conditions: MINOCA

Treatments: Diagnostic Test: CMR

Study type: Observational

Funder types: Other

Identifiers

NCT06889428

HREC/15/TQEH/252 - SWEET

Details and patient eligibility

About

Myocardial Infarction (MI) with Non-Obstructive Coronary Arteries (MINOCA), occurring in 6-8% of MIs, refers to patients who experience a heart attack without obstructive coronary artery disease (CAD) or significant atherosclerosis. One of the challenges inherent to MINOCA lies in its propensity to mimic non-coronary-related pathologies, such as myocarditis or takotsubo. Thus, Cardiac Magnetic Resonance (MRI) imaging has been recommended as the central diagnostic tool for confirming MINOCA diagnosis while excluding the others. However, the resource-intensive nature of MRI, combined with its limited availability in hospitals, poses barriers to patient access and limits research activities that could produce significant impact. Therefore, this project's aim is to curate the largest dataset of suspected MINOCA patients with MRI, via a collaboration between Sweden's nationwide registry and South Australia's state-wide registry, to answer the following key questions: (i) What is prognosis of MINOCA, as confirmed by MRI? (ii) What are the characteristics and prognosis of patients who had MRI compared to those who did not? (iii) What clinical parameters are associated with MINOCA on MRI?

This project will utilize DataSHIELD, an innovative platform that enables pooled statistical analysis of sensitive data without compromising individual-level privacy. This multicentre, comprehensive study will have a major impact on contemporary practice. It will be able to provide the significance of MINOCA diagnosis (myocardial scar on MRI), alongside identifying clinical factors associated with its occurrence and its correlation with long-term outcomes.

This is crucial for informing clinical guidelines, policy decisions around reimbursement for MRI, and developing effective clinical trials to enhance the management of MRI-confirmed MINOCA patients

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Discharge diagnosis of MINOCA - acute presentation with (a) universal criteria for acute MI (b) non-obstructive coronaries on angiography.
2. Cardiac MRI - at least within 3 months of acute presentation

Exclusion criteria

1. Patients without satisfactory images on cardiac MRI
2. Follow-up data not available (ie international visitors).
3. Suspicion of an alternative cause for presentation (such as sepsis, pulmonary embolus, primary cardiac arrhythmia or trauma) which would not be consistent with the label of MINOCA.
4. Clinically evident non-ischemic diagnoses - myocarditis, Takotsubo, other cardiomyopathies prior to CMR

Trial design

1,000 participants in 4 patient groups

Suspected MINOCA with CMR

Description:

Patients who have undergone a CMR procedure as part of their care at the time of acute presentation with MI.

Treatment:

Diagnostic Test: CMR

Suspected MINOCA without CMR

Description:

Patients who did not undergo a CMR procedure as part of their care at the time of acute presentation with MI.

Patients with confirmed MINOCA

Description:

Suspected MINOCA patients who have received a diagnosis of MI following CMR

Treatment:

Diagnostic Test: CMR

Patients with other CMR diagnosis

Description:

Suspected MINOCA patients who did not receive a diagnosis of MI following CMR