Recruiting

Platelet Sub-Study

Sponsor:

NYU Langone Health

Code:

NCT03022552

Conditions

Myocardial Infarction

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Myocardial Infarction

Study ID

NCT03022552

Start date

Jul 1, 2020

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

MINOCA

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

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).

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jeffrey Berger, MD

212 263 4004jeffrey.berger@nyumc.org

Harmony R Reynolds, MD

917-693-7070harmony.reynolds@nyumc.org

Locations

NYU Langone Medical Center

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • Myocardial Infarction
  • Platelets
  • Blood Collection
  • Genomics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-04-20.