Clinical trial NCT06889428: Prognostic Significance of CMR-Confirmed Infarct in MINOCA Patients from Sweden and Australia
Official title: Prognostic Significance of Cardiac Magnetic Resonance Imaging Confirmed Infarct in MINOCA Patients from Sweden and Australia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MINOCA
Keywords: cardiac magnetic resonance imaging
prognosis
Myocarditis
Lead sponsor: University of Adelaide
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2025-03-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Experiencing Major Adverse Cardiovascular Events (MACE)
timeFrame: 36 Months
Secondary outcomes:
measure: Percentage of Participants with All-Cause Mortality
timeFrame: 36 Months
measure: Percentage of Participants with Cardiac Mortality
timeFrame: 36 Months
measure: Percentage of Participants with Myocardial Infarction (Re-Infarction)
timeFrame: 36 Months
measure: Percentage of Participants with Hospital admission for Unstable Angina
timeFrame: 36 Months
measure: Percentage of Participants Hospitalized for Heart Failure
timeFrame: 36 Months
measure: Percentage of Participants Experiencing a Stroke
timeFrame: 36 Months
measure: Percentage of Participants with All-Cause Mortality
timeFrame: 12 Months
measure: Percentage of Participants with Cardiac Mortality
timeFrame: 12 Months
measure: Percentage of Participants with Myocardial Infarction (Re-Infarction)
timeFrame: 12 Months
measure: Percentage of Participants with Hospital admission for Unstable Angina
timeFrame: 12 Months
measure: Percentage of Participants Hospitalized for Heart Failure
timeFrame: 12 Months
measure: Percentage of Participants Experiencing a Stroke
timeFrame: 12 Months
measure: Percentage of Participants Presenting to the Emergency Department with Chest Pain
timeFrame: 36 Months
measure: Percentage of Participants Presenting to the Emergency Department with Chest Pain
timeFrame: 12 Months
measure: Percentage of Participants with Late Gadolinium Enhancement (LGE) Features on CMR Following suspected MINOCA
timeFrame: From CMR performed within 3 months from acute presentation
measure: Percentage of Participants with Abnormal Tissue Characteristics on CMR in Suspected MINOCA
timeFrame: From CMR performed within 3 months from acute presentation
measure: Percentage of Participants with Evidence of Myocarditis on CMR in Suspected MINOCA
timeFrame: From CMR performed within 3 months from acute presentation
measure: Percentage of Participants with Evidence of Takotsubo Syndrome on CMR in Suspected MINOCA
timeFrame: From CMR performed within 3 months from acute presentation
measure: Percentage of Participants with Normal CMR Findings in Suspected MINOCA
timeFrame: From CMR performed within 3 months from acute presentation
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: University of Adelaide
state: South Australia
Study officials:
affiliation: University of Adelaide
name: John Beltrame, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Bertil Lindahl
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Adelaide
name: Sivabaskari Pasupathy, PhD
role: PRINCIPAL_INVESTIGATOR
References: