Women's Heart Attack Research Program: Platelet Sub-Study (HARP)
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 99 |
| Updated: | 5/25/2018 |
| Start Date: | August 2016 |
| End Date: | April 2020 |
| Contact: | Jeffrey Berger, MD |
| Email: | jeffrey.berger@nyumc.org |
| Phone: | 212 263 4004 |
Women's Heart Attack Research Program: Platelet Sub-Study (HARP); Platelet Collection for Women With Myocardial Infarction
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.
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.
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
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