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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

Titles & IDs
Public title
Prognostic Significance of CMR-Confirmed Infarct in MINOCA Patients from Sweden and Australia
Scientific title
Prognostic Significance of Cardiac Magnetic Resonance Imaging Confirmed Infarct in MINOCA Patients from Sweden and Australia
Secondary ID [1] 0 0
HREC/15/TQEH/252 - SWEET
Universal Trial Number (UTN)
Trial acronym
SWEET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
MINOCA 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Experiencing Major Adverse Cardiovascular Events (MACE)
Timepoint [1] 0 0
36 Months
Secondary outcome [1] 0 0
Percentage of Participants with All-Cause Mortality
Timepoint [1] 0 0
36 Months
Secondary outcome [2] 0 0
Percentage of Participants with Cardiac Mortality
Timepoint [2] 0 0
36 Months
Secondary outcome [3] 0 0
Percentage of Participants with Myocardial Infarction (Re-Infarction)
Timepoint [3] 0 0
36 Months
Secondary outcome [4] 0 0
Percentage of Participants with Hospital admission for Unstable Angina
Timepoint [4] 0 0
36 Months
Secondary outcome [5] 0 0
Percentage of Participants Hospitalized for Heart Failure
Timepoint [5] 0 0
36 Months
Secondary outcome [6] 0 0
Percentage of Participants Experiencing a Stroke
Timepoint [6] 0 0
36 Months
Secondary outcome [7] 0 0
Percentage of Participants with All-Cause Mortality
Timepoint [7] 0 0
12 Months
Secondary outcome [8] 0 0
Percentage of Participants with Cardiac Mortality
Timepoint [8] 0 0
12 Months
Secondary outcome [9] 0 0
Percentage of Participants with Myocardial Infarction (Re-Infarction)
Timepoint [9] 0 0
12 Months
Secondary outcome [10] 0 0
Percentage of Participants with Hospital admission for Unstable Angina
Timepoint [10] 0 0
12 Months
Secondary outcome [11] 0 0
Percentage of Participants Hospitalized for Heart Failure
Timepoint [11] 0 0
12 Months
Secondary outcome [12] 0 0
Percentage of Participants Experiencing a Stroke
Timepoint [12] 0 0
12 Months
Secondary outcome [13] 0 0
Percentage of Participants Presenting to the Emergency Department with Chest Pain
Timepoint [13] 0 0
36 Months
Secondary outcome [14] 0 0
Percentage of Participants Presenting to the Emergency Department with Chest Pain
Timepoint [14] 0 0
12 Months
Secondary outcome [15] 0 0
Percentage of Participants with Late Gadolinium Enhancement (LGE) Features on CMR Following suspected MINOCA
Timepoint [15] 0 0
From CMR performed within 3 months from acute presentation
Secondary outcome [16] 0 0
Percentage of Participants with Abnormal Tissue Characteristics on CMR in Suspected MINOCA
Timepoint [16] 0 0
From CMR performed within 3 months from acute presentation
Secondary outcome [17] 0 0
Percentage of Participants with Evidence of Myocarditis on CMR in Suspected MINOCA
Timepoint [17] 0 0
From CMR performed within 3 months from acute presentation
Secondary outcome [18] 0 0
Percentage of Participants with Evidence of Takotsubo Syndrome on CMR in Suspected MINOCA
Timepoint [18] 0 0
From CMR performed within 3 months from acute presentation
Secondary outcome [19] 0 0
Percentage of Participants with Normal CMR Findings in Suspected MINOCA
Timepoint [19] 0 0
From CMR performed within 3 months from acute presentation

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2024
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
5005 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Uppsala University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Beltrame, PhD
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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