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

NYU Langone Health

Status: Enrolling

Conditions: Myocardial Infarction

Study type: Observational

Funder types: Other

Identifiers

NCT03022552

16-01104-3

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: Female

Ages: 21 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

350 participants in 3 patient groups

MINOCA

Description:

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

Description:

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

Description:

Women with stable angina that are age and race matched to women in the MINOCA arm that are clinically referred for cardiac catheterization