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Recruiting NCT03022552

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

— Observational Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Myocardial Infarction. Basic parameters: 21 years — 99 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Examination of Platelet Activity Markers [Time frame: 1 year]
  • Examination of Markers of Cardiovascular Disease Risk [Time frame: 1 year]
  • Cellular and molecular mechanism of myocardial infarction in women [Time frame: 1 year]
Secondary outcome measures (1)
  • Examination of non-coding and coding mRNA profiles in women with MI and matched controls [Time frame: 4 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • NYU Langone Medical Center — New York

Publications

  • 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. PMID 40126944
  • 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. PMID 34496250
  • 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. PMID 30562118

Identifiers

NCT: NCT03022552 · 16-01104-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗