Imaging study for heart attack diagnosis

Heart Attack Research Program- Imaging Study

This study is testing advanced imaging methods to help understand why some people have heart attacks even when their coronary arteries aren't blocked.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 21 Years to 99 Years
• Sex: All
• Sponsor: NYU Langone Health (other)
• Locations: 19 sites (Birmingham, Alabama and 18 other locations)
• Trial ID: NCT02905357 on ClinicalTrials.gov

What this trial studies

The HARP study is a multi-center observational study that focuses on patients experiencing myocardial infarction with non-obstructive coronary arteries (MINOCA). Participants will undergo advanced imaging techniques, including optical coherence tomography (OCT) and cardiac magnetic resonance imaging (CMR), to identify the underlying causes of their heart attack. The study will follow participants for up to 10 years to monitor for any recurrent clinical events. This approach aims to enhance understanding of MINOCA and improve diagnostic accuracy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older who have experienced acute ischemic symptoms and have objective evidence of myocardial infarction without significant coronary artery stenosis.

Not a fit: Patients with known obstructive coronary artery disease or significant stenosis in major epicardial vessels will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better diagnosis and management of patients with MINOCA, potentially improving outcomes.

How similar studies have performed: Other studies have explored imaging techniques in myocardial infarction, but the specific focus on MINOCA with this methodology is relatively novel.

Eligibility criteria

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)

Where this trial is running

Birmingham, Alabama and 18 other locations

• University of Alabama-Birmingham — Birmingham, Alabama, United States (COMPLETED)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (ACTIVE_NOT_RECRUITING)
• UC San Diego Medical Center — San Diego, California, United States (ACTIVE_NOT_RECRUITING)
• Stanford University — Stanford, California, United States (ACTIVE_NOT_RECRUITING)
• University of Florida Medical Center — Gainesville, Florida, United States (ACTIVE_NOT_RECRUITING)
• Emory University — Atlanta, Georgia, United States (ACTIVE_NOT_RECRUITING)
• Johns Hopkins Medical Center — Baltimore, Maryland, United States (ACTIVE_NOT_RECRUITING)
• Dartmouth-Hitchcock — Lebanon, New Hampshire, United States (ACTIVE_NOT_RECRUITING)
• NYU Winthrop — Mineola, New York, United States (RECRUITING)
• NYU Langone Medical Center — New York, New York, United States (RECRUITING)
• Columbia University Medical Center/NYPH — New York, New York, United States (COMPLETED)
• Ohio State University Medical Center — Columbus, Ohio, United States (ACTIVE_NOT_RECRUITING)
• St. Luke's University Health Network — Bethlehem, Pennsylvania, United States (ACTIVE_NOT_RECRUITING)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (ACTIVE_NOT_RECRUITING)
• Seton Heart (Ascension) Univeristy of Austin, Texas — Austin, Texas, United States (ACTIVE_NOT_RECRUITING)
• University of Alberta — Edmonton, Alberta, Canada (ACTIVE_NOT_RECRUITING)
• Vancouver General Hospital — Vancouver, British Columbia, Canada (ACTIVE_NOT_RECRUITING)
• St. Boniface General Hospital — Winnipeg, Manitoba, Canada (ACTIVE_NOT_RECRUITING)
• University of Calgary — Calgary, Canada (ACTIVE_NOT_RECRUITING)

Study contacts

• Principal investigator: Harmony R Reynolds, MD — NYU Langone Medical Center
• Study coordinator: Harmony R Reynolds, MD

Conditions: Myocardial Infarction, Imaging