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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06889428
Registration number
NCT06889428
Ethics application status
Date submitted
10/03/2025
Date registered
25/03/2025
Date last updated
26/03/2025
Titles & IDs
Public title
Prognostic Significance of CMR-Confirmed Infarct in MINOCA Patients from Sweden and Australia
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Scientific title
Prognostic Significance of Cardiac Magnetic Resonance Imaging Confirmed Infarct in MINOCA Patients from Sweden and Australia
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Secondary ID [1]
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HREC/15/TQEH/252 - SWEET
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Universal Trial Number (UTN)
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Trial acronym
SWEET
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
MINOCA
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - CMR
Suspected MINOCA with CMR - Patients who have undergone a CMR procedure as part of their care at the time of acute presentation with MI.
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
Patients with other CMR diagnosis - Suspected MINOCA patients who did not receive a diagnosis of MI following CMR
Diagnosis / Prognosis: CMR
No CMR
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Experiencing Major Adverse Cardiovascular Events (MACE)
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Assessment method [1]
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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.
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Timepoint [1]
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36 Months
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Secondary outcome [1]
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Percentage of Participants with All-Cause Mortality
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Assessment method [1]
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Proportion of participants who experience death from any cause following MINOCA.
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Timepoint [1]
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36 Months
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Secondary outcome [2]
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Percentage of Participants with Cardiac Mortality
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Assessment method [2]
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Proportion of participants who experience death due to a cardiac cause following MINOCA
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Timepoint [2]
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36 Months
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Secondary outcome [3]
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Percentage of Participants with Myocardial Infarction (Re-Infarction)
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Assessment method [3]
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Proportion of participants who are re-admitted for myocardial infarction following MINOCA
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Timepoint [3]
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36 Months
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Secondary outcome [4]
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Percentage of Participants with Hospital admission for Unstable Angina
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Assessment method [4]
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Proportion of participants who are admitted for unstable angina following MINOCA.
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Timepoint [4]
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36 Months
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Secondary outcome [5]
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Percentage of Participants Hospitalized for Heart Failure
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Assessment method [5]
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The proportion of participants who require hospitalization due to heart failure following MINOCA
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Timepoint [5]
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36 Months
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Secondary outcome [6]
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Percentage of Participants Experiencing a Stroke
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Assessment method [6]
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The proportion of participants who experience a stroke following MINOCA
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Timepoint [6]
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36 Months
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Secondary outcome [7]
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Percentage of Participants with All-Cause Mortality
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Assessment method [7]
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Proportion of participants who experience death from any cause following MINOCA.
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Timepoint [7]
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12 Months
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Secondary outcome [8]
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Percentage of Participants with Cardiac Mortality
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Assessment method [8]
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Proportion of participants who experience death due to a cardiac cause following MINOCA
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Timepoint [8]
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12 Months
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Secondary outcome [9]
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Percentage of Participants with Myocardial Infarction (Re-Infarction)
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Assessment method [9]
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Proportion of participants who are re-admitted for myocardial infarction following MINOCA
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Timepoint [9]
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12 Months
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Secondary outcome [10]
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Percentage of Participants with Hospital admission for Unstable Angina
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Assessment method [10]
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Proportion of participants who are admitted for unstable angina following MINOCA.
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Timepoint [10]
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12 Months
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Secondary outcome [11]
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Percentage of Participants Hospitalized for Heart Failure
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Assessment method [11]
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The proportion of participants who require hospitalization due to heart failure following MINOCA
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Timepoint [11]
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12 Months
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Secondary outcome [12]
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Percentage of Participants Experiencing a Stroke
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Assessment method [12]
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The proportion of participants who experience a stroke following MINOCA
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Timepoint [12]
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12 Months
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Secondary outcome [13]
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Percentage of Participants Presenting to the Emergency Department with Chest Pain
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Assessment method [13]
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The proportion of participants who present to the emergency department with chest pain, expressed as a percentage of the total study population.
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Timepoint [13]
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36 Months
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Secondary outcome [14]
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Percentage of Participants Presenting to the Emergency Department with Chest Pain
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Assessment method [14]
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The proportion of participants who present to the emergency department with chest pain, expressed as a percentage of the total study population.
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Timepoint [14]
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12 Months
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Secondary outcome [15]
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Percentage of Participants with Late Gadolinium Enhancement (LGE) Features on CMR Following suspected MINOCA
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Assessment method [15]
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The proportion of participants with detectable LGE on cardiac magnetic resonance (CMR) , indicating myocardial fibrosis or necrosis.
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Timepoint [15]
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From CMR performed within 3 months from acute presentation
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Secondary outcome [16]
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Percentage of Participants with Abnormal Tissue Characteristics on CMR in Suspected MINOCA
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Assessment method [16]
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The proportion of participants with suspected MINOCA who exhibit abnormal myocardial tissue characteristics on CMR, including myocardial edema,
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Timepoint [16]
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From CMR performed within 3 months from acute presentation
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Secondary outcome [17]
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Percentage of Participants with Evidence of Myocarditis on CMR in Suspected MINOCA
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Assessment method [17]
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The proportion of participants with suspected MINOCA who have CMR findings consistent with myocarditis (e.g., myocardial edema, LGE patterns suggestive of inflammation).
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Timepoint [17]
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From CMR performed within 3 months from acute presentation
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Secondary outcome [18]
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Percentage of Participants with Evidence of Takotsubo Syndrome on CMR in Suspected MINOCA
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Assessment method [18]
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The proportion of participants with suspected MINOCA who demonstrate CMR findings consistent with Takotsubo syndrome (e.g., apical ballooning, absence of LGE).
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Timepoint [18]
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From CMR performed within 3 months from acute presentation
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Secondary outcome [19]
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Percentage of Participants with Normal CMR Findings in Suspected MINOCA
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Assessment method [19]
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The proportion of participants with suspected MINOCA who have no significant abnormalities on CMR, indicating no structural or ischemic myocardial injury.
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Timepoint [19]
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From CMR performed within 3 months from acute presentation
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2024
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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University of Adelaide - Adelaide
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Recruitment postcode(s) [1]
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5005 - Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Adelaide
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Uppsala University
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT06889428
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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John Beltrame, PhD
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Address
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University of Adelaide
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06889428
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