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

Prognostic Significance of Cardiac Magnetic Resonance Imaging Confirmed Infarct in MINOCA Patients from Sweden and Australia

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 Overview

• Status: Completed
• Conditions: MINOCA
• Intervention / Treatment: Diagnostic test: CMR

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5005
      • University of Adelaide

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The data will extracted from CADOSA and SWEDEHEART registries for the purpose of this study.

• CADOSA (Australia): The Coronary Angiogram Database Of South Australia registry is highly robust, collecting detailed and comprehensive information on patients undergoing coronary angiogram procedure in South Australia. It includes patient features, comorbidities, chest pain and ECG characteristics, coronay angiogram details, admission/discharge medications etc. Data is collected directly from patients and medical records in real-time by trained collectors, ensuring data quality and reliability.
• SWEDEHEART (Sweden): The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) registry is a comprehensive and nationwide registry in Sweden that focuses on the management and treatment of patients with cardiovascular diseases.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected MINOCA with CMR; Patients who have undergone a CMR procedure as part of their care at the time of acute presentation with MI.	Diagnostic test: CMR; No CMR; Other Names: Cardiac MRI; Cardiac magnetic resonance imaging
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.
Patients with confirmed MINOCA; Suspected MINOCA patients who have received a diagnosis of MI following CMR	Diagnostic test: CMR; No CMR; Other Names: Cardiac MRI; Cardiac magnetic resonance imaging
Patients with other CMR diagnosis; Suspected MINOCA patients who did not receive a diagnosis of MI following CMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Experiencing Major Adverse Cardiovascular Events (MACE)	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.	36 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with All-Cause Mortality	Proportion of participants who experience death from any cause following MINOCA.	36 Months
Percentage of Participants with Cardiac Mortality	Proportion of participants who experience death due to a cardiac cause following MINOCA	36 Months
Percentage of Participants with Myocardial Infarction (Re-Infarction)	Proportion of participants who are re-admitted for myocardial infarction following MINOCA	36 Months
Percentage of Participants with Hospital admission for Unstable Angina	Proportion of participants who are admitted for unstable angina following MINOCA.	36 Months
Percentage of Participants Hospitalized for Heart Failure	The proportion of participants who require hospitalization due to heart failure following MINOCA	36 Months
Percentage of Participants Experiencing a Stroke	The proportion of participants who experience a stroke following MINOCA	36 Months
Percentage of Participants with All-Cause Mortality	Proportion of participants who experience death from any cause following MINOCA.	12 Months
Percentage of Participants with Cardiac Mortality	Proportion of participants who experience death due to a cardiac cause following MINOCA	12 Months
Percentage of Participants with Myocardial Infarction (Re-Infarction)	Proportion of participants who are re-admitted for myocardial infarction following MINOCA	12 Months
Percentage of Participants with Hospital admission for Unstable Angina	Proportion of participants who are admitted for unstable angina following MINOCA.	12 Months
Percentage of Participants Hospitalized for Heart Failure	The proportion of participants who require hospitalization due to heart failure following MINOCA	12 Months
Percentage of Participants Experiencing a Stroke	The proportion of participants who experience a stroke following MINOCA	12 Months
Percentage of Participants Presenting to the Emergency Department with Chest Pain	The proportion of participants who present to the emergency department with chest pain, expressed as a percentage of the total study population.	36 Months
Percentage of Participants Presenting to the Emergency Department with Chest Pain	The proportion of participants who present to the emergency department with chest pain, expressed as a percentage of the total study population.	12 Months
Percentage of Participants with Late Gadolinium Enhancement (LGE) Features on CMR Following suspected MINOCA	The proportion of participants with detectable LGE on cardiac magnetic resonance (CMR) , indicating myocardial fibrosis or necrosis.	From CMR performed within 3 months from acute presentation
Percentage of Participants with Abnormal Tissue Characteristics on CMR in Suspected MINOCA	The proportion of participants with suspected MINOCA who exhibit abnormal myocardial tissue characteristics on CMR, including myocardial edema,	From CMR performed within 3 months from acute presentation
Percentage of Participants with Evidence of Myocarditis on CMR in Suspected MINOCA	The proportion of participants with suspected MINOCA who have CMR findings consistent with myocarditis (e.g., myocardial edema, LGE patterns suggestive of inflammation).	From CMR performed within 3 months from acute presentation
Percentage of Participants with Evidence of Takotsubo Syndrome on CMR in Suspected MINOCA	The proportion of participants with suspected MINOCA who demonstrate CMR findings consistent with Takotsubo syndrome (e.g., apical ballooning, absence of LGE).	From CMR performed within 3 months from acute presentation
Percentage of Participants with Normal CMR Findings in Suspected MINOCA	The proportion of participants with suspected MINOCA who have no significant abnormalities on CMR, indicating no structural or ischemic myocardial injury.	From CMR performed within 3 months from acute presentation

Collaborators and Investigators

• Sponsor: University of Adelaide
• Collaborators: Uppsala University
• Investigators: Principal Investigator: John Beltrame, PhD, University of Adelaide; Principal Investigator: Bertil Lindahl, Uppsala University; Principal Investigator: Sivabaskari Pasupathy, PhD, University of Adelaide

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: prognosis; cardiac magnetic resonance imaging; Myocarditis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; MINOCA
• Other Study ID Numbers: HREC/15/TQEH/252 - SWEET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For privacy reasons, the IPD will not be shared between countries

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No