Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000540415
Ethics application status
Approved
Date submitted
29/11/2024
Date registered
28/05/2025
Date last updated
28/05/2025
Date data sharing statement initially provided
28/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Diagnose underlying aetiology with Intravascular Assessment versus Cardiac Magnetic Resonance Imaging in patients with Myocardial Infarction with Non-Obstructive Coronary Arteries (DETECT-MINOCA)
Scientific title
Diagnose underlying aetiology with Intravascular Assessment versus Cardiac Magnetic Resonance Imaging in patients with Myocardial Infarction with Non-Obstructive Coronary Arteries (DETECT-MINOCA)
Secondary ID [1] 313494 0
None
Universal Trial Number (UTN)
Trial acronym
DETECT-MINOCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction 335913 0
Condition category
Condition code
Cardiovascular 332504 332504 0 0
Other cardiovascular diseases
Cardiovascular 332503 332503 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
DETECT-MINOCA Algorithmic Pathway (Intervention Arm)
- Participants randomised to the DETECT-MINOCA algorithm undergo further investigation stratified by their Left Ventricular Ejection Fraction (LVEF) and regional wall motion patterns:

A) Patients with preserved LVEF or regional wall motion abnormalities:

- Optical Coherence Tomography (OCT):
Performed immediately following coronary angiography in the catheterisation lab. OCT uses a near-infrared light source delivered via an intracoronary catheter to image vessel morphology with high resolution. A small amount of contrast (~15mL) is used during image acquisition per vessel. The procedure takes approximately 10–15 minutes.for one vessel and 15-20 minutes for all 3 epicardial vessels.

- Acetylcholine (ACh) Provocation Testing (optional):
If OCT does not yield a definitive diagnosis, intracoronary ACh is administered to test for vasospasm. A 20–100 µg dose is injected directly into the coronary artery, with angiographic monitoring for vasoconstriction and symptoms. This adds approximately 5 minutes to the procedure. In some cases (e.g., RCA testing), a temporary pacing wire may be inserted as a safety precaution.

- Cardiac Magnetic Resonance Imaging (CMR):
If both OCT and ACh-provocation yields no diagnosis, CMR is performed as an inpatient prior to discharge. It involves a 30–40 minute scanning session with cine imaging, late gadolinium enhancement (LGE), and T1/T2 mapping. Gadolinium contrast (0.2 mmol/kg) is administered intravenously. CMR identifies both ischaemic and non-ischaemic myocardial injury.

B) Patients with reduced LVEF and regional wall motion abnormality:
These patients also proceed with OCT ± ACh testing, prioritising the vessel corresponding to the affected myocardial territory. If no pathology is found in the suspected culprit artery, OCT ± ACh may be extended to the remaining vessels. CMR is conducted if invasive testing yields no diagnosis.

C) Patients with globally reduced LVEF (diffuse hypokinesis):
These patients bypass invasive assessment and proceed directly to CMR.

Timing:
All invasive assessments (OCT ± ACh) are conducted within the index coronary angiogram procedure (i.e., immediately after angiographic diagnosis of MINOCA). CMR, if indicated, is performed within the index hospital admission, typically within 2–3 days of admission.
Intervention code [1] 330069 0
Diagnosis / Prognosis
Comparator / control treatment
The control arm consists of a CMR-first strategy following diagnostic coronary angiography confirming Myocardial Infarction with Non-Obstructive Coronary Arteries (MINOCA).

Participants randomised to this arm do not undergo further intravascular assessment. Instead, all patients undergo CMR as the initial diagnostic investigation, conducted during the index hospital admission.

CMR Protocol:
A comprehensive contrast-enhanced CMR scan is performed using 1.5T or 3T MRI systems. The protocol includes cine imaging, rest perfusion, late gadolinium enhancement (LGE), and T1/T2 mapping to evaluate cardiac structure, function, oedema, and fibrosis.
A gadolinium-based contrast agent (0.2 mmol/kg) is administered intravenously, with image acquisition lasting approximately 30–40 minutes.

Timing:
CMR is performed within the same hospital admission, typically within 2–3 days post angiography.

Purpose:
This comparator arm reflects standard diagnostic practice at many Australian centres, where CMR is often used to evaluate patients with suspected MINOCA due to its non-invasive nature and diagnostic capability for non-ischaemic causes such as myocarditis and Takotsubo cardiomyopathy.
Control group
Active

Outcomes
Primary outcome [1] 340028 0
Proportion of patients with a final MINOCA endotype diagnosis on hospital discharge.
Timepoint [1] 340028 0
Assessed on patient discharge from hospital.
Secondary outcome [1] 442385 0
Composite safety outcome (Acute Kidney Injury, peri-procedural MI, major bleeding, or stroke)
Timepoint [1] 442385 0
At time of hospital discharge
Secondary outcome [2] 447498 0
Proportion of patients who underwent both CMR and IVA
Timepoint [2] 447498 0
Assessed at time of discharge
Secondary outcome [3] 442387 0
Quality of life via survey
Timepoint [3] 442387 0
Will be assessed once during hospital stay after the CMR or invasive intravascular imaging, prior to hospital discharge.
Secondary outcome [4] 442384 0
Length of stay in hospital
Timepoint [4] 442384 0
Assessed at hospital discharge
Secondary outcome [5] 442383 0
Proportion of patients with a final MINOCA endotype diagnosis after first investigation post angiogram.
Timepoint [5] 442383 0
Assessed after first investigation (intravascular assessment or CMR)
Secondary outcome [6] 442386 0
Angina frequency collected via survery
Timepoint [6] 442386 0
Will be assessed once during hospital stay after the CMR or invasive intravascular imaging, prior to hospital discharge.

Eligibility
Key inclusion criteria
- Adult men and women aged over 18
- Acute coronary syndrome with a raised high-sensitivity troponin.
- No other obvious competing causes of demand ischaemia eg. arrhythmia, PE, sepsis.
- Clinically referred for invasive coronary angiography
- Coronary angiography diagnosis of non-obstructive coronary arteries (0.8)
- Able to personally read and understand the Participant Information and Consent Form and provide written, signed and data informed consent to participate in study (health care interpreters will be engaged for people with cultural and linguistically diverse backgrounds).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cardiogenic shock
- Coronary angiography revealing obstructive coronary arteries (above or equal to 50% stenosis)
- Acute myocardial infarction with fibrinolytic therapy
- Stage IV/V Kidney disease ie. estimated glomerular filtration rate < 30 ml/m2
- Active internal bleeding
- Previous coronary artery bypass surgery
- Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test done prior to enrolment
- Inability to provide informed consent (compromised mental status e.g., dementia, too ill) for clinically indicated coronary angiography
- Currently a prisoner (has been admitted to hospital via a correctional facility)
- Contraindications to contrast
- Heavily calcified or tortuous vessels leading inability to advance OCT
- Contraindications to cardiac magnetic resonance imaging (CMR) eg. metal implants, incompatible pacemaker/defibrillator, metal rods, screws, plates

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation process
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
1/07/2027
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
106
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317931 0
Government body
Name [1] 317931 0
Sydney Local Health District
Country [1] 317931 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 320280 0
None
Name [1] 320280 0
Address [1] 320280 0
Country [1] 320280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316615 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316615 0
Ethics committee country [1] 316615 0
Australia
Date submitted for ethics approval [1] 316615 0
16/10/2024
Approval date [1] 316615 0
21/02/2025
Ethics approval number [1] 316615 0

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

Contacts
Principal investigator
Name 138426 0
Prof Andy Yong
Address 138426 0
Concord General Repatriation Hospital, Hospital Road, Concord, NSW 2139
Country 138426 0
Australia
Phone 138426 0
+61 2 9767 5000
Fax 138426 0
Email 138426 0
[email protected]
Contact person for public queries
Name 138427 0
Dr Chinmay Khandkar
Address 138427 0
Royal Prince Alfred Hospital, Missenden Road, Camperdown NSW 2050
Country 138427 0
Australia
Phone 138427 0
+612 9515 6111
Fax 138427 0
Email 138427 0
[email protected]
Contact person for scientific queries
Name 138428 0
Dr Chinmay Khandkar
Address 138428 0
Royal Prince Alfred Hospital, Missenden Road, Camperdown NSW 2050
Country 138428 0
Australia
Phone 138428 0
+612 9515 6111
Fax 138428 0
Email 138428 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.