Official Title
Heart Attack Research Program: Platelet Sub-Study (HARP); Platelet Collection for Patients With Myocardial Infarction
Brief Title
Heart Attack Research Program: Platelet Sub-Study (HARP)
Protocol ID
NCT03022552
Lead Sponsor
NYU Langone Health
Brief Summary
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.
Study Period
-
Enrollment Count
350 participants
Eligibility Criteria
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
Filters
Myocardial Infarction
RECRUITING
ADULT
OLDER_ADULT