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

Myocardial Infarction Clinical Trial

— HARP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03022552
• Other study ID #: 16-01104-3
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Jeffrey Berger, MD
• Phone: 212 263 4004
• Email: jeffrey.berger[@]nyumc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination of Platelet Activity Markers		1 year
Primary	Examination of Markers of Cardiovascular Disease Risk	This will include additional examination of known thrombosis, Inflammation, metabolic disease, and lipids/lipoprotein markers.	1 year
Primary	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	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