Women's Heart Attack Research Program- Imaging Study (HARP)
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|ClinicalTrials.gov Identifier: NCT02905357|
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment|
|Myocardial Infarction||Device: OCT Other: CMR|
Women's HARP is a multi-center, observational study which enrolls women with MI who are referred for cardiac catheterization. Eligible participants with MINOCA (defined as no stenosis of >50% in any major epicardial vessel) will undergo optical coherence tomography (OCT) at the time of diagnostic angiography and cardiac magnetic resonance imaging (CMR).
Participants will also have the option to enroll in the HARP- Stress Ancillary Study and HARP-Platelet Sub-Study.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Women's Heart Attack Research Program- Imaging Study|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
OCT and CMR imaging
Optical Coherence Tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.
Screen failures with MI found to have obstructive CAD. Limited data collection for comparison to MINOCA cohort.
Cardiac Magnetic Resonance Imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (swelling).
- Proportion of women with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis) [ Time Frame: 1 week ]
- Proportion of women with MINOCA who have spontaneous coronary dissection. [ Time Frame: 1 week ]
- Proportion of women with MINOCA who have late gadolinium enhancement and/or myocardial edema [ Time Frame: 1 week ]
- Correlation of the presence and location of myocardial abnormalities on CMR with presence and location of plaque disruption on OCT among women with MINOCA. [ Time Frame: 1 week ]
- Proportion of patients for whom an etiology can be clearly identified after combining OCT and CMR. [ Time Frame: 1 week ]
- Area under curve of clinical prediction model for plaque disruption on OCT in women with MINOCA. [ Time Frame: 1 week ]
- Composite clinical endpoint: Death, unstable angina, stroke, recurrent MI, catheterizations and revascularization, other cardiac hospitalization. [ Time Frame: 3 years ]components of composite will also be examined
- Perceived stress [ Time Frame: 1 week ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905357
|Contact: Harmony R Reynolds, MDemail@example.com|
|Principal Investigator:||Harmony R Reynolds, MD||NYU Langone Medical Center|