Heart Attack Research Program- Imaging Study
- Conditions
- Myocardial Infarction
- Interventions
- Device: OCTOther: CMR
- Registration Number
- NCT02905357
- Lead Sponsor
- NYU Langone Health
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
-
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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MINOCA OCT OCT and CMR imaging MI-CAD CMR Screen failures with MI found to have obstructive CAD. Limited data collection for comparison to MINOCA cohort.
- Primary Outcome Measures
Name Time Method Proportion of patients with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis) 1 week
- Secondary Outcome Measures
Name Time Method Proportion of patients with MINOCA who have spontaneous coronary dissection. 1 week Proportion of patients for whom an etiology can be clearly identified after combining OCT and CMR. 1 week Proportion of patients with MINOCA who have late gadolinium enhancement and/or myocardial edema 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. 1 week Area under curve of clinical prediction model for plaque disruption on OCT in patients with MINOCA. 1 week
Trial Locations
- Locations (19)
Emory University
🇺🇸Atlanta, Georgia, United States
Stanford University
🇺🇸Stanford, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Florida Medical Center
🇺🇸Gainesville, Florida, United States
Seton Heart (Ascension) Univeristy of Austin, Texas
🇺🇸Austin, Texas, United States
St. Luke's University Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Johns Hopkins Medical Center
🇺🇸Baltimore, Maryland, United States
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
Dartmouth-Hitchcock
🇺🇸Lebanon, New Hampshire, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
NYU Winthrop
🇺🇸Mineola, New York, United States
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
University of Calgary
🇨🇦Calgary, Canada
UC San Diego Medical Center
🇺🇸San Diego, California, United States
University of Alabama-Birmingham
🇺🇸Birmingham, Alabama, United States
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada