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

Recruiting

• Conditions: Myocardial Infarction

• Registration Number: NCT03022552
• Lead Sponsor: NYU Langone Health

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 available

Study Timeline

• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-16
• Study Start: 2020-07-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 350

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cellular and molecular mechanism of myocardial infarction in women	1 year	To further investigate this mechanism, recent advances in microRNA, RNA, DNA expression profiling, and plasma and serum collections will be used.
Examination of Platelet Activity Markers	1 year
Examination of Markers of Cardiovascular Disease Risk	1 year	This will include additional examination of known thrombosis, Inflammation, metabolic disease, and lipids/lipoprotein markers.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States