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

NCT ID: NCT03022552

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MINOCA

Women with myocardial infarction (MI) with demonstrated non-obstructive coronary artery disease during cardiac catheterization (less than 50% blockage in any major vessel).

No interventions assigned to this group

MI-CAD

Women with myocardial infarction (MI) with demonstrated obstructive coronary artery disease during cardiac catheterization (50% or greater blockage in any major vessel) or previous history of percutaneous coronary intervention (PCI) or or coronary artery bypass graft (CABG).

No interventions assigned to this group

CATH-NOCA

Women with stable angina that are age and race matched to women in the MINOCA arm that are clinically referred for cardiac catheterization

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harmony R Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

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NYU Langone Medical Center

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeffrey Berger, MD

Role: CONTACT

212 263 4004

Harmony R Reynolds, MD

Role: CONTACT

646-501-0302

Facility Contacts

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Jeffrey Berger, MD

Role: primary

References

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Sowa MA, Hannemann C, Pinos I, Ferreira E, Biwas B, Dai M, Corr EM, Cornwell MG, Drenkova K, Lee AH, Spruill T, Reynolds HR, Hochman JS, Ruggles KV, Campbell RA, van Solingen C, Wright MD, Moore KJ, Berger JS, Barrett TJ. Tetraspanin CD37 regulates platelet hyperreactivity and thrombosis. Cardiovasc Res. 2025 Jun 12;121(6):943-956. doi: 10.1093/cvr/cvaf051.

Reference Type DERIVED
PMID: 40126944 (View on PubMed)

Barrett TJ, Corr EM, van Solingen C, Schlamp F, Brown EJ, Koelwyn GJ, Lee AH, Shanley LC, Spruill TM, Bozal F, de Jong A, Newman AAC, Drenkova K, Silvestro M, Ramkhelawon B, Reynolds HR, Hochman JS, Nahrendorf M, Swirski FK, Fisher EA, Berger JS, Moore KJ. Chronic stress primes innate immune responses in mice and humans. Cell Rep. 2021 Sep 7;36(10):109595. doi: 10.1016/j.celrep.2021.109595.

Reference Type DERIVED
PMID: 34496250 (View on PubMed)

Barrett TJ, Lee AH, Smilowitz NR, Hausvater A, Fishman GI, Hochman JS, Reynolds HR, Berger JS. Whole-Blood Transcriptome Profiling Identifies Women With Myocardial Infarction With Nonobstructive Coronary Artery Disease. Circ Genom Precis Med. 2018 Dec;11(12):e002387. doi: 10.1161/CIRCGEN.118.002387. No abstract available.

Reference Type DERIVED
PMID: 30562118 (View on PubMed)

Other Identifiers

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16-01104-3

Identifier Type: -

Identifier Source: org_study_id

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