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Heart Attack Research Program- Imaging Study

RECRUITINGSponsored by NYU Langone Health
Actively Recruiting
SponsorNYU Langone Health
Started2020-07-01
Est. completion2027-06-30
Eligibility
Age21 Years – 99 Years
Healthy vol.Accepted
Locations15 sites

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

Age: 21 Years – 99 YearsHealthy volunteers accepted
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)

Conditions2

Heart DiseaseMyocardial Infarction

Locations15 sites

University of Alabama-Birmingham
Birmingham, Alabama, 35294
Cedars-Sinai Medical Center
Los Angeles, California, 90048
UC San Diego Medical Center
San Diego, California, 92103
Stanford University
Stanford, California, 94305
University of Florida Medical Center
Gainesville, Florida, 32603

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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