Heart Attack Research Program- Imaging Study (HARP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02905357|
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : August 12, 2021
|Condition or disease||Intervention/treatment|
|Myocardial Infarction||Device: OCT Other: CMR|
HARP is a multi-center, observational study which enrolls men and 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-Platelet Sub-Study.
|Study Type :||Observational|
|Estimated Enrollment :||450 participants|
|Official Title:||Heart Attack Research Program- Imaging Study|
|Actual Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||June 30, 2025|
|Estimated Study Completion Date :||June 30, 2025|
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 patients with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis) [ Time Frame: 1 week ]
- Proportion of patients with MINOCA who have spontaneous coronary dissection. [ Time Frame: 1 week ]
- Proportion of patients 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 patients with MINOCA. [ Time Frame: 1 week ]
- Composite clinical endpoint: Death, unstable angina, stroke, recurrent MI, catheterizations and revascularization, other cardiac hospitalization. [ Time Frame: 10 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, MDfirstname.lastname@example.org|
|Principal Investigator:||Harmony R Reynolds, MD||NYU Langone Medical Center|