NCT03022552 Heart Attack Research Program: Platelet Sub-Study (HARP)
| NCT ID | NCT03022552 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Myocardial Infarction |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2020-07-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2020-07-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Harmony R Reynolds, MD
PRINCIPAL INVESTIGATOR
NYU Langone Medical Center
Frequently Asked Questions
Who can join the NCT03022552 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 99 Years, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03022552 currently recruiting?
Yes, NCT03022552 is actively recruiting participants. Contact the research team at jeffrey.berger@nyumc.org for enrollment information.
Where is the NCT03022552 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT03022552 clinical trial?
NCT03022552 is sponsored by NYU Langone Health. The principal investigator is Harmony R Reynolds, MD at NYU Langone Medical Center. The trial plans to enroll 350 participants.