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Women's Heart Attack Research Program: Platelet Sub-Study (HARP); Platelet Collection for Women With Myocardial Infarction (NCT03022552)

This prospective observational cohort study, will investigate the platelet phenotype, platelet genetic composition, and role of platelets as effector cells in women with myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at NYU and Bellevue Medical Center, may have concurrent enrollment with the HARP Main Imaging (NCT02914483) and HARP Stress Ancillary Studies (NCT02270359). Additionally, a group of age and race matched disease controls 'CATH-NOCA' composed of women with stable angina referred for cardiac catheterization, will be enrolled. Blood obtained during the initial catheterization, 2 months post-MI, and following the stress study (for those participants enrolled in the stress study) will be utilized for platelet testing.
Ages eligible for Study
21 Years to 99 Years
Genders eligible for Study
Female
Accepts Healthy 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
  • Age ≥ 21 years
  • Female sex
  • 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 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

1 locations

United States (1)
  • NYU Langone Medical Center
    recruiting
    New York, New York, United States, 10016
Status:
recruiting
Type:
Observational Patient Registry
Phase:
-
Start:
31 July, 2016
Updated:
12 January, 2017
Participants:
200
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