OCT: Optical Coherence Tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.
CMR: Cardiac Magnetic Resonance Imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (swelling).
Study summary
The HARP study is a multi-center, diagnostic observational study employing standardized imaging protocols in patients with MINOCA (MI with Non Obstructive Coronary Arteries) to determine the underlying diagnosis in each participant. Participants will be followed for recurrent clinical events, every 6 months, for a maximum of 10 years.
Eligibility
Sex
ALL
Min age
21 Years
Max age
99 Years
Healthy volunteers
No
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
* ST segment elevation of ≥1mm on 2 contiguous ECG leads
* Willing to provide informed consent and comply with all aspects of the protocol
* Age ≥ 21 years
Exclusion Criteria:
* Stenosis ≥50% of any major epicardial vessel on invasive angiography, as determined by the angiographer at the time of clinically ordered cardiac catheterization
* History of known obstructive coronary artery disease at angiography, including history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
* 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
* Coronary dissection apparent on angiography
* Excessive coronary tortuosity which, in the angiographer's opinion, increases the risks of OCT
* eGFR\<45 or contraindication to additional contrast needed for OCT in the opinion of the angiographer or treating physician
* Contraindication to MRI (including but not limited to ferromagnetic implants)
* Pregnancy
* Thrombolytic therapy for STEMI (qualifying event)
Primary outcome measure(s)
Proportion of patients with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis) — 1 week
Trial sites (20)
Facility
City
Region
Status
University of Alabama-Birmingham
Birmingham
Alabama
Cedars-Sinai Medical Center
Los Angeles
California
UC San Diego Medical Center
San Diego
California
Stanford University
Stanford
California
University of Florida Medical Center
Gainesville
Florida
Emory University
Atlanta
Georgia
Johns Hopkins Medical Center
Baltimore
Maryland
Dartmouth-Hitchcock
Lebanon
New Hampshire
NYU Winthrop
Mineola
New York
NYU Langone Medical Center
New York
New York
Columbia University Medical Center/NYPH
New York
New York
Ohio State University Medical Center
Columbus
Ohio
St. Luke's University Health Network
Bethlehem
Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
Seton Heart (Ascension) Univeristy of Austin, Texas
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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