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

NCT ID: NCT06889428

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2024-12-31

Brief Summary

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

Conditions

MINOCA

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Suspected MINOCA with CMR

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

CMR

Intervention Type: DIAGNOSTIC_TEST

No CMR

Suspected MINOCA without CMR

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

No interventions assigned to this group

Patients with confirmed MINOCA

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

CMR

Intervention Type: DIAGNOSTIC_TEST

No CMR

Patients with other CMR diagnosis

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

No interventions assigned to this group

Interventions

CMR

No CMR

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Cardiac magnetic resonance imaging; Cardiac MRI

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

University of Adelaide

OTHER

Sponsor Role: lead

Responsible Party

Sivabaskari Pasupathy

Principal Investigator (Research Fellow)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Beltrame, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Adelaide

Bertil Lindahl

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Sivabaskari Pasupathy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Adelaide

Locations

University of Adelaide

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

HREC/15/TQEH/252 - SWEET

Identifier Type: -

Identifier Source: org_study_id