Status:
ACTIVE_NOT_RECRUITING
Heart Attack Research Program- Imaging Study
Lead Sponsor:
NYU Langone Health
Conditions:
Myocardial Infarction
Eligibility:
All Genders
21-99 years
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 underlyin...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 12 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT02905357
Start Date
September 12 2016
End Date
June 30 2027
Last Update
March 11 2026
Active Locations (19)
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1
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
UC San Diego Medical Center
San Diego, California, United States, 92103
4
Stanford University
Stanford, California, United States, 94305