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

Heart Attack Research Program: Platelet Sub-Study (HARP); Platelet Collection for Patients With Myocardial Infarction

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03022552
Acronym
HARP
Enrollment
350
Registered
2017-01-16
Start date
2020-07-01
Completion date
2027-06-30
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction, Platelets, Blood Collection, Genomics

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.

Interventions

None listed

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Examination of Platelet Activity Markers1 year
Examination of Markers of Cardiovascular Disease Risk1 yearThis will include additional examination of known thrombosis, Inflammation, metabolic disease, and lipids/lipoprotein markers.
Cellular and molecular mechanism of myocardial infarction in women1 yearTo further investigate this mechanism, recent advances in microRNA, RNA, DNA expression profiling, and plasma and serum collections will be used.

Secondary

MeasureTime frameDescription
Examination of non-coding and coding mRNA profiles in women with MI and matched controls4 yearsSpecific transcripts associated with platelet activation, plaque destabilization, and different cardiovascular diseases will be analyzed at the genetic level.

Countries

United States

Contacts

CONTACTJeffrey Berger, MD
jeffrey.berger@nyumc.org212 263 4004
CONTACTHarmony R Reynolds, MD
harmony.reynolds@nyumc.org917-693-7070
PRINCIPAL_INVESTIGATORHarmony R Reynolds, MD

NYU Langone Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026