AzTrials
AzTrials

MINOCASWEETNCT06889428

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

An observational study of MINOCA, run by University of Adelaide at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
MINOCA
What is being tested?
CMR
How many people
1,000 participants
Where
1 siteAustralia
Study dates
1 Jan 2017to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • University of Adelaide

    Adelaide, South Australia, 5005

Other trials in Australia

About this study

Official title: 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

Conditions
MINOCA
Being tested
CMR
Keywords
cardiac magnetic resonance imaging, prognosis, Myocarditis
Medical subject headings
MINOCA, Myocarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMRDiagnostic test

    Also called Cardiac magnetic resonance imaging, Cardiac MRI

    No CMR

Study groups in NCT06889428
Study groupRoleWhat they receive
Suspected MINOCA with CMRPatients who have undergone a CMR procedure as part of their care at the time of acute presentation with MI.
Receives: Diagnostic Test: CMR
Suspected MINOCA without CMRPatients who did not undergo a CMR procedure as part of their care at the time of acute presentation with MI.
Patients with confirmed MINOCASuspected MINOCA patients who have received a diagnosis of MI following CMR
Receives: Diagnostic Test: CMR
Patients with other CMR diagnosisSuspected MINOCA patients who did not receive a diagnosis of MI following CMR

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 36 Months

Secondary outcomes (19)

  1. Percentage of Participants with All-Cause Mortality

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

    Measured: 36 Months

  2. Percentage of Participants with Cardiac Mortality

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

    Measured: 36 Months

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

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

    Measured: 36 Months

  4. Percentage of Participants with Hospital admission for Unstable Angina

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

    Measured: 36 Months

  5. Percentage of Participants Hospitalized for Heart Failure

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

    Measured: 36 Months

  6. Percentage of Participants Experiencing a Stroke

    The proportion of participants who experience a stroke following MINOCA

    Measured: 36 Months

  7. Percentage of Participants with All-Cause Mortality

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

    Measured: 12 Months

  8. Percentage of Participants with Cardiac Mortality

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

    Measured: 12 Months

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

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

    Measured: 12 Months

  10. Percentage of Participants with Hospital admission for Unstable Angina

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

    Measured: 12 Months

  11. Percentage of Participants Hospitalized for Heart Failure

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

    Measured: 12 Months

  12. Percentage of Participants Experiencing a Stroke

    The proportion of participants who experience a stroke following MINOCA

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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,

    Measured: 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).

    Measured: 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).

    Measured: 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.

    Measured: From CMR performed within 3 months from acute presentation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2025
  2. Study start1 Jan 2017
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06889428
Sponsor's protocol ID
HREC/15/TQEH/252 - SWEET
Acronym
SWEET
Status last verified
Mar 2025
First submitted
10 Mar 2025
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: For privacy reasons, the IPD will not be shared between countries

Questions about this trial

What is this clinical trial studying?

An observational study of MINOCA, run by University of Adelaide at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Experiencing Major Adverse Cardiovascular Events (MACE) (time frame: 36 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06889428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in