Heart Attack Research Program- Imaging Study (HARP)

April 1, 2024 updated by: NYU Langone Health
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Calgary, Canada
        • Active, not recruiting
        • University of Calgary
    • Alberta
      • Edmonton, Alberta, Canada
        • Active, not recruiting
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Active, not recruiting
        • Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Active, not recruiting
        • St. Boniface General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Completed
        • University of Alabama-Birmingham
    • California
      • Los Angeles, California, United States, 90048
        • Active, not recruiting
        • Cedars-Sinai Medical Center
      • San Diego, California, United States, 92103
        • Active, not recruiting
        • UC San Diego Medical Center
      • Stanford, California, United States, 94305
        • Active, not recruiting
        • Stanford University
    • Florida
      • Gainesville, Florida, United States, 32603
        • Active, not recruiting
        • University of Florida Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Active, not recruiting
        • Emory University
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Active, not recruiting
        • Johns Hopkins Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Active, not recruiting
        • Dartmouth-Hitchcock
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Winthrop
        • Contact:
          • Wendy Drewes
        • Principal Investigator:
          • Kevin Marzo
        • Sub-Investigator:
          • Juan Gaztanaga
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Medical Center
        • Contact:
      • New York, New York, United States, 10032
        • Completed
        • Columbia University Medical Center/NYPH
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Active, not recruiting
        • Ohio State University Medical Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Active, not recruiting
        • St. Luke's University Health Network
      • Pittsburgh, Pennsylvania, United States, 15213
        • Active, not recruiting
        • University of Pittsburgh Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Active, not recruiting
        • Seton Heart (Ascension) Univeristy of Austin, Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men and women with MI and no coronary stenosis of 50% or greater on angiography, consecutive.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MINOCA
OCT and CMR imaging
Device: OCT
Optical Coherence Tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.
MI-CAD
Screen failures with MI found to have obstructive CAD. Limited data collection for comparison to MINOCA cohort.
Other: CMR
Cardiac Magnetic Resonance Imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (swelling).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis)
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with MINOCA who have spontaneous coronary dissection.
Time Frame: 1 week
1 week
Proportion of patients with MINOCA who have late gadolinium enhancement and/or myocardial edema
Time Frame: 1 week
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.
Time Frame: 1 week
1 week
Proportion of patients for whom an etiology can be clearly identified after combining OCT and CMR.
Time Frame: 1 week
1 week
Area under curve of clinical prediction model for plaque disruption on OCT in patients with MINOCA.
Time Frame: 1 week
1 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite clinical endpoint: Death, unstable angina, stroke, recurrent MI, catheterizations and revascularization, other cardiac hospitalization.
Time Frame: 10 years
components of composite will also be examined
10 years
Perceived stress
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Harmony R Reynolds, MD, NYU Langone Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimated)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-01104-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared after the end of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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