Prognostic Significance of Cardiac Magnetic Resonance Imaging Confirmed Infarct in MINOCA Patients from Sweden and Australia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Adelaide
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Experiencing Major Adverse Cardiovascular Events (MACE)
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Discharge diagnosis of MINOCA - acute presentation with (a) universal criteria for acute MI (b) non-obstructive coronaries on angiography.
- •Cardiac MRI - at least within 3 months of acute presentation
Exclusion Criteria
- •Patients without satisfactory images on cardiac MRI
- •Follow-up data not available (ie international visitors).
- •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.
- •Clinically evident non-ischemic diagnoses - myocarditis, Takotsubo, other cardiomyopathies prior to CMR
Outcomes
Primary Outcomes
Percentage of Participants Experiencing Major Adverse Cardiovascular Events (MACE)
Time Frame: 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 Outcomes
- Percentage of Participants with All-Cause Mortality(12 Months)
- Percentage of Participants with Cardiac Mortality(12 Months)
- Percentage of Participants with Myocardial Infarction (Re-Infarction)(12 Months)
- Percentage of Participants with Hospital admission for Unstable Angina(12 Months)
- Percentage of Participants with Evidence of Takotsubo Syndrome on CMR in Suspected MINOCA(From CMR performed within 3 months from acute presentation)
- Percentage of Participants Hospitalized for Heart Failure(12 Months)
- Percentage of Participants Experiencing a Stroke(12 Months)
- Percentage of Participants Presenting to the Emergency Department with Chest Pain(12 Months)
- Percentage of Participants with Late Gadolinium Enhancement (LGE) Features on CMR Following suspected MINOCA(From CMR performed within 3 months from acute presentation)
- Percentage of Participants with Abnormal Tissue Characteristics on CMR in Suspected MINOCA(From CMR performed within 3 months from acute presentation)
- Percentage of Participants with Evidence of Myocarditis on CMR in Suspected MINOCA(From CMR performed within 3 months from acute presentation)
- Percentage of Participants with Normal CMR Findings in Suspected MINOCA(From CMR performed within 3 months from acute presentation)
Investigators
Sivabaskari Pasupathy
Principal Investigator (Research Fellow)
University of Adelaide