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

NCT03022552 | Recruiting DMC

• 1 other identifier: 16-01104-3
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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

Keywords

Myocardial Infarction; Platelets; Blood Collection; Genomics

Outcome Measures

Primary Outcomes (3)

• Examination of Platelet Activity Markers

  1 year

• Examination of Markers of Cardiovascular Disease Risk

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

  1 year

• Cellular and molecular mechanism of myocardial infarction in women

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

  1 year

Secondary Outcomes (1)

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

  4 years

Study Arms (3)

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

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study may have concurrent enrollment with the HARP Main Imaging (NCT02905357). This study population includes women and men who present to the hospital with an MI, with non-obstructive coronary artery disease or obstructive artery disease, are eligible for blood collection. Additionally, a sex, group of age and race matched disease controls 'CATH-NOCA' will be composed of women and men with stable angina referred for cardiac catheterization.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

RECRUITING

Related Publications (3)

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood Collection

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Harmony R Reynolds, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Berger, MD

CONTACT

212 263 4004; jeffrey.berger@nyumc.org

Harmony R Reynolds, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 16, 2017
• Study Start: July 1, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)