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

NCT06889428 | Completed

• 1 other identifier: HREC/15/TQEH/252 - SWEET
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

cardiac magnetic resonance imaging; prognosis; Myocarditis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Percentage of Participants with All-Cause Mortality

  36 Months

• Percentage of Participants with Cardiac Mortality

  36 Months

• Percentage of Participants with Myocardial Infarction (Re-Infarction)

  36 Months

• Percentage of Participants with Hospital admission for Unstable Angina

  36 Months

• Percentage of Participants Hospitalized for Heart Failure

  36 Months

Study Arms (4)

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

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

Patients with other CMR diagnosis

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

Interventions

CMR DIAGNOSTIC_TEST

No CMR

Also known as: Cardiac magnetic resonance imaging, Cardiac MRI

Patients with confirmed MINOCA; Suspected MINOCA with CMR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Adelaide: lead
• Uppsala University: collaborator

Study Sites (1)

University of Adelaide

Adelaide, South Australia, 5005, Australia

Location

MeSH Terms

Conditions

MINOCA; Myocarditis

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cardiomyopathies

Study Officials

• John Beltrame, PhD

  University of Adelaide

  PRINCIPAL INVESTIGATOR

• Bertil Lindahl

  Uppsala University

  PRINCIPAL INVESTIGATOR

• Sivabaskari Pasupathy, PhD

  University of Adelaide

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Research Fellow)

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 21, 2025
• Study Start: January 1, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)