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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Jeffrey Berger, MD; Phone Number: 212 263 4004; Email: jeffrey.berger@nyumc.org
• Study Contact Backup: Name: Harmony R Reynolds, MD; Phone Number: 917-693-7070; Email: harmony.reynolds@nyumc.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Medical Center
      • Contact: Jeffrey Berger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examination of non-coding and coding mRNA profiles in women with MI and matched controls	Specific transcripts associated with platelet activation, plaque destabilization, and different cardiovascular diseases will be analyzed at the genetic level.	4 years

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Harmony R Reynolds, MD, NYU Langone Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimated): January 16, 2017

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Genomics; Myocardial Infarction; Platelets; Blood Collection
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction
• Other Study ID Numbers: 16-01104-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared after the end of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No