Heart Attack Research Program- Imaging Study

Study Overview
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Brief Summary
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The HARP study is a multi-center, diagnostic observational study employing standardized imaging protocols in patients with MINOCA (MI with Non Obstructive Coronary Arteries) to determine the underlying diagnosis in each participant. Participants will be followed for recurrent clinical events, every 6 months, for a maximum of 10 years.

Detailed Description
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HARP is a multi-center, observational study which enrolls men and women with MI who are referred for cardiac catheterization. Eligible participants with MINOCA (defined as no stenosis of >50% in any major epicardial vessel) will undergo optical coherence tomography (OCT) at the time of diagnostic angiography and cardiac magnetic resonance imaging (CMR). Participants will also have the option to enroll in the HARP-Platelet Sub-Study.

Official Title
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Heart Attack Research Program- Imaging Study

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Device: OCT
* Other: CMR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ischemic symptoms compatible with diagnosis of MI, such as chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms Objective evidence of MI (either or both of the following): Elevation of troponin to above the laboratory upper limit of normal ST segment elevation of ≥1mm on 2 contiguous ECG leads Willing to provide informed consent and comply with all aspects of the protocol Age ≥ 21 years Exclusion Criteria: Stenosis ≥50% of any major epicardial vessel on invasive angiography, as determined by the angiographer at the time of clinically ordered cardiac catheterization History of known obstructive coronary artery disease at angiography, including history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) Recent use of vasospastic agents, such as cocaine, triptans, or ergot alkaloids (≤1 month) Alternate explanation for troponin elevation, such as hypertensive urgency, acute exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary embolism, cardiac trauma Coronary dissection apparent on angiography Excessive coronary tortuosity which, in the angiographer's opinion, increases the risks of OCT eGFR<45 or contraindication to additional contrast needed for OCT in the opinion of the angiographer or treating physician Contraindication to MRI (including but not limited to ferromagnetic implants) Pregnancy Thrombolytic therapy for STEMI (qualifying event)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MINOCA<br>OCT and CMR imaging | Device: OCT<br>* Optical Coherence Tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.<br>|
| MI-CAD<br>Screen failures with MI found to have obstructive CAD. Limited data collection for comparison to MINOCA cohort. | Other: CMR<br>* Cardiac Magnetic Resonance Imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (swelling).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis) |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with MINOCA who have spontaneous coronary dissection. |  | 1 week | 
| Proportion of patients with MINOCA who have late gadolinium enhancement and/or myocardial edema |  | 1 week | 
| Correlation of the presence and location of myocardial abnormalities on CMR with presence and location of plaque disruption on OCT among women with MINOCA. |  | 1 week | 
| Proportion of patients for whom an etiology can be clearly identified after combining OCT and CMR. |  | 1 week | 
| Area under curve of clinical prediction model for plaque disruption on OCT in patients with MINOCA. |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarction, Imaging