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CompletedNCT06889428SWEETUpdated Mar 26, 2025

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

An observational study in MINOCA, sponsored by University of Adelaide. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by University of Adelaide · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • MINOCA

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Keywords

  • cardiac magnetic resonance imaging
  • prognosis
  • Myocarditis
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In context

MINOCA

29 studies on the registry are indexed under MINOCA; 18 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 500 across 20 observational studies indexed under MINOCA.

Browse MINOCA studies →

Lead sponsor

University of Adelaide is the lead sponsor of 42 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testCMR

    No CMR

    Also known as: Cardiac magnetic resonance imaging, Cardiac MRI

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What researchers measure

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.

    Time frame: 36 Months

Secondary outcomes

  1. Percentage of Participants with All-Cause Mortality

    Proportion of participants who experience death from any cause following MINOCA.

    Time frame: 36 Months

  2. Percentage of Participants with Cardiac Mortality

    Proportion of participants who experience death due to a cardiac cause following MINOCA

    Time frame: 36 Months

  3. Percentage of Participants with Myocardial Infarction (Re-Infarction)

    Proportion of participants who are re-admitted for myocardial infarction following MINOCA

    Time frame: 36 Months

  4. Percentage of Participants with Hospital admission for Unstable Angina

    Proportion of participants who are admitted for unstable angina following MINOCA.

    Time frame: 36 Months

  5. Percentage of Participants Hospitalized for Heart Failure

    The proportion of participants who require hospitalization due to heart failure following MINOCA

    Time frame: 36 Months

  6. Percentage of Participants Experiencing a Stroke

    The proportion of participants who experience a stroke following MINOCA

    Time frame: 36 Months

  7. Percentage of Participants with All-Cause Mortality

    Proportion of participants who experience death from any cause following MINOCA.

    Time frame: 12 Months

  8. Percentage of Participants with Cardiac Mortality

    Proportion of participants who experience death due to a cardiac cause following MINOCA

    Time frame: 12 Months

  9. Percentage of Participants with Myocardial Infarction (Re-Infarction)

    Proportion of participants who are re-admitted for myocardial infarction following MINOCA

    Time frame: 12 Months

  10. Percentage of Participants with Hospital admission for Unstable Angina

    Proportion of participants who are admitted for unstable angina following MINOCA.

    Time frame: 12 Months

  11. Percentage of Participants Hospitalized for Heart Failure

    The proportion of participants who require hospitalization due to heart failure following MINOCA

    Time frame: 12 Months

  12. Percentage of Participants Experiencing a Stroke

    The proportion of participants who experience a stroke following MINOCA

    Time frame: 12 Months

  13. 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.

    Time frame: 36 Months

  14. 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.

    Time frame: 12 Months

  15. 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.

    Time frame: From CMR performed within 3 months from acute presentation

  16. 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,

    Time frame: From CMR performed within 3 months from acute presentation

  17. 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).

    Time frame: From CMR performed within 3 months from acute presentation

  18. 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).

    Time frame: From CMR performed within 3 months from acute presentation

  19. 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.

    Time frame: From CMR performed within 3 months from acute presentation

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Study locations

1 site
  • University of Adelaide
    Adelaide, South Australia 5005, Australia
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References and documents

Individual participant data

Plan to share: No — For privacy reasons, the IPD will not be shared between countries

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06889428
Lead sponsor
University of Adelaide
Collaborators
Uppsala University
Responsible party
Sivabaskari Pasupathy (Principal Investigator (Research Fellow), University of Adelaide) — Principal investigator
First posted
Mar 21, 2025
Start date
Jan 1, 2017
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Mar 26, 2025

Study contacts

John Beltrame, PhD
principal investigator · University of Adelaide
Bertil Lindahl
principal investigator · Uppsala University
Sivabaskari Pasupathy, PhD
principal investigator · University of Adelaide

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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