Heart Attack Research Program- Imaging Study (HARP)

  • STATUS
    Recruiting
  • days left to enroll
    51
  • participants needed
    450
  • sponsor
    NYU Langone Health
Updated on 12 September 2025

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.

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.

Details
Condition Myocardial Infarction
Age 21years - 99years
Clinical Study IdentifierNCT02905357
SponsorNYU Langone Health
Last Modified on12 September 2025

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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