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

Completed

• Conditions: MINOCA

• Registration Number: NCT06889428
• Lead Sponsor: University of Adelaide

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-15
• Last Update Submitted: 2025-03-23
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Major Adverse Cardiovascular Events (MACE)	36 Months	The proportion of participants experiencing the first occurrence of MACE, defined as all-cause mortality, cardiac mortality, myocardial infarction, unstable angina, heart failure hospitalization, or stroke following MINOCA.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with All-Cause Mortality	12 Months	Proportion of participants who experience death from any cause following MINOCA.
Percentage of Participants with Cardiac Mortality	12 Months	Proportion of participants who experience death due to a cardiac cause following MINOCA
Percentage of Participants with Myocardial Infarction (Re-Infarction)	12 Months	Proportion of participants who are re-admitted for myocardial infarction following MINOCA
Percentage of Participants with Hospital admission for Unstable Angina	12 Months	Proportion of participants who are admitted for unstable angina following MINOCA.
Percentage of Participants with Evidence of Takotsubo Syndrome on CMR in Suspected MINOCA	From CMR performed within 3 months from acute presentation	The proportion of participants with suspected MINOCA who demonstrate CMR findings consistent with Takotsubo syndrome (e.g., apical ballooning, absence of LGE).
Percentage of Participants Hospitalized for Heart Failure	12 Months	The proportion of participants who require hospitalization due to heart failure following MINOCA
Percentage of Participants Experiencing a Stroke	12 Months	The proportion of participants who experience a stroke following MINOCA
Percentage of Participants Presenting to the Emergency Department with Chest Pain	12 Months	The proportion of participants who present to the emergency department with chest pain, expressed as a percentage of the total study population.
Percentage of Participants with Late Gadolinium Enhancement (LGE) Features on CMR Following suspected MINOCA	From CMR performed within 3 months from acute presentation	The proportion of participants with detectable LGE on cardiac magnetic resonance (CMR) , indicating myocardial fibrosis or necrosis.
Percentage of Participants with Abnormal Tissue Characteristics on CMR in Suspected MINOCA	From CMR performed within 3 months from acute presentation	The proportion of participants with suspected MINOCA who exhibit abnormal myocardial tissue characteristics on CMR, including myocardial edema,
Percentage of Participants with Evidence of Myocarditis on CMR in Suspected MINOCA	From CMR performed within 3 months from acute presentation	The proportion of participants with suspected MINOCA who have CMR findings consistent with myocarditis (e.g., myocardial edema, LGE patterns suggestive of inflammation).
Percentage of Participants with Normal CMR Findings in Suspected MINOCA	From CMR performed within 3 months from acute presentation	The proportion of participants with suspected MINOCA who have no significant abnormalities on CMR, indicating no structural or ischemic myocardial injury.

Trial Locations

Locations (1)

University of Adelaide; 🇦🇺 Adelaide, South Australia, Australia