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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 99
Healthy Volunteers: t
View:

• 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

Locations
United States
New York
NYU Langone Medical Center
RECRUITING
New York
Contact Information
Primary
Jeffrey Berger, MD
jeffrey.berger@nyumc.org
212 263 4004
Backup
Harmony R Reynolds, MD
harmony.reynolds@nyumc.org
646-501-0302
Time Frame
Start Date: 2020-07-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 350
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov

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