Heart Attack Research Program: Platelet Sub-Study (HARP)

Study Overview
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Brief Summary
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This prospective observational cohort study, will investigate the platelet phenotype, platelet genetic composition, and role of platelets as effector cells in women and men with myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at NYU and Bellevue Medical Center, and participating external sites. May have concurrent enrollment with the HARP Main Imaging (NCT02914483). Additionally, a sex, group of age and race matched disease controls 'CATH-NOCA' composed of women and men with stable angina referred for cardiac catheterization, will be enrolled. Blood obtained during the initial catheterization and 2 months post-MI will be utilized for platelet testing.

Official Title
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Heart Attack Research Program: Platelet Sub-Study (HARP); Platelet Collection for Patients With Myocardial Infarction

Conditions
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Myocardial Infarction

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 (ULN) ST segment elevation of ≥1mm on 2 contiguous ECG leads Willing to provide informed consent and comply with all aspects of the protocol Administration of aspirin at least 1 hour before cardiac catheterization Administration of thienopyridine (e.g., clopidogrel, ticagrelor) at least 1 hour before cardiac catheterization Women and men with ≥50% of any major epicardial vessel on invasive angiography may participate Exclusion Criteria: 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 Pregnancy Thrombolytic therapy for STEMI (qualifying event) Use of any of the following medications: Platelet antagonists (except aspirin and thienopyridines) within 7 days NSAIDs (e.g., ibuprofen, naproxen) within 3 days. Thrombocytopenia (platelet count <100,000) Thrombocytosis (platelet count >500,000) Anemia (hemoglobin <9 mg/dl) Hemorrhagic diathesis

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

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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>Women with myocardial infarction (MI) with demonstrated non-obstructive coronary artery disease during cardiac catheterization (less than 50% blockage in any major vessel). | |
| MI-CAD<br>Women with myocardial infarction (MI) with demonstrated obstructive coronary artery disease during cardiac catheterization (50% or greater blockage in any major vessel) or previous history of percutaneous coronary intervention (PCI) or or coronary artery bypass graft (CABG). | |
| CATH-NOCA<br>Women with stable angina that are age and race matched to women in the MINOCA arm that are clinically referred for cardiac catheterization | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examination of Platelet Activity Markers |  | 1 year | 
| Examination of Markers of Cardiovascular Disease Risk | This will include additional examination of known thrombosis, Inflammation, metabolic disease, and lipids/lipoprotein markers. | 1 year | 
| Cellular and molecular mechanism of myocardial infarction in women | To further investigate this mechanism, recent advances in microRNA, RNA, DNA expression profiling, and plasma and serum collections will be used. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examination of non-coding and coding mRNA profiles in women with MI and matched controls | Specific transcripts associated with platelet activation, plaque destabilization, and different cardiovascular diseases will be analyzed at the genetic level. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarction, Platelets, Blood Collection, Genomics