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

• ClinicalTrials.gov Identifier: NCT03022552
• Recruitment Status: Recruiting
• First Posted: January 16, 2017
• Last Update Posted: April 2, 2024
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Tracking Information

• First Submitted Date: January 13, 2017
• First Posted Date: January 16, 2017
• Last Update Posted Date: April 2, 2024
• Actual Study Start Date: July 1, 2020
• Estimated Primary Completion Date: June 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 13, 2017)

• Examination of Platelet Activity Markers [ Time Frame: 1 year ]
• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 13, 2017)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Heart Attack Research Program: Platelet Sub-Study (HARP)
• Official Title: Heart Attack Research Program: Platelet Sub-Study (HARP); Platelet Collection for Patients With Myocardial Infarction
• 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.
• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 6 Months

Biospecimen

Retention:   Samples With DNA

Description:

Blood Collection

• 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.
• Condition: Myocardial Infarction
• Intervention: Not Provided

Study Groups/Cohorts

• 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

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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 15, 2020): 350
• Original Estimated Enrollment (submitted: January 13, 2017): 200
• Estimated Study Completion Date: June 30, 2025
• Estimated Primary Completion Date: June 30, 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 21 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Jeffrey Berger, MD; 212 263 4004; jeffrey.berger@nyumc.org

Contact: Harmony R Reynolds, MD; 646-501-0302; harmony.reynolds@nyumc.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03022552
• Other Study ID Numbers: 16-01104-3
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: De-identified data will be shared after the end of the study.

• Current Responsible Party: NYU Langone Health
• Original Responsible Party: Same as current
• Current Study Sponsor: NYU Langone Health
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Harmony R Reynolds, MD; NYU Langone Medical Center

• PRS Account: NYU Langone Health
• Verification Date: April 2024