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NCT Number: NCT03022552

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

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.

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Key information

Age range

21 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

NYU Langone Medical Center

New York, 10016, United States

Location status: Recruiting

Location contact

Jeffrey Berger, MD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Examination of Platelet Activity Markers

    Time frame: 1 year

  2. Examination of Markers of Cardiovascular Disease Risk

    Time frame: 1 year

    This will include additional examination of known thrombosis, Inflammation, metabolic disease, and lipids/lipoprotein markers.

  3. Cellular and molecular mechanism of myocardial infarction in women

    Time frame: 1 year

    To further investigate this mechanism, recent advances in microRNA, RNA, DNA expression profiling, and plasma and serum collections will be used.

Secondary outcomes

  1. Examination of non-coding and coding mRNA profiles in women with MI and matched controls

    Time frame: 4 years

    Specific transcripts associated with platelet activation, plaque destabilization, and different cardiovascular diseases will be analyzed at the genetic level.

Study contacts

Contact information is provided by the study sponsor or research team.

Harmony R Reynolds, MD

CONTACT

[email protected]

917-693-7070

Jeffrey Berger, MD

CONTACT

[email protected]

212 263 4004

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Acronym: HARP

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2017
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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