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Active, not recruitingNCT02905357HARPUpdated Mar 19, 2026

Heart Attack Research Program- Imaging Study

An observational study in Myocardial Infarction, sponsored by NYU Langone Health. Active, not recruiting at 20 sites in 3 countries. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by NYU Langone Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
450
Ages
21 Years to 99 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Myocardial Infarction

Keywords

  • Myocardial Infarction
  • Imaging
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In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 450 is close to the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 99 Years
Sexes eligible
All
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.

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

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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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
450 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • MINOCA

    OCT and CMR imaging

    Device: OCT

  • MI-CAD

    Screen failures with MI found to have obstructive CAD. Limited data collection for comparison to MINOCA cohort.

    Other: CMR

Interventions

  • DeviceOCT

    Optical Coherence Tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.

  • OtherCMR

    Cardiac Magnetic Resonance Imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (swelling).

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What researchers measure

Primary outcomes

  1. Proportion of patients with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis)

    Time frame: 1 week

Secondary outcomes

  1. Proportion of patients with MINOCA who have spontaneous coronary dissection.

    Time frame: 1 week

  2. Proportion of patients with MINOCA who have late gadolinium enhancement and/or myocardial edema

    Time frame: 1 week

  3. 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

  4. Proportion of patients for whom an etiology can be clearly identified after combining OCT and CMR.

    Time frame: 1 week

  5. Area under curve of clinical prediction model for plaque disruption on OCT in patients with MINOCA.

    Time frame: 1 week

Other outcomes

  1. Composite clinical endpoint: Death, unstable angina, stroke, recurrent MI, catheterizations and revascularization, other cardiac hospitalization.

    components of composite will also be examined

    Time frame: 10 years

  2. Perceived stress

    Time frame: 1 week

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Study locations

20 sites
  • University of Alabama-Birmingham
    Birmingham, Alabama 35294, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • UC San Diego Medical Center
    San Diego, California 92103, United States
  • Stanford University
    Stanford, California 94305, United States
  • University of Florida Medical Center
    Gainesville, Florida 32603, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • Johns Hopkins Medical Center
    Baltimore, Maryland 21287, United States
  • Dartmouth-Hitchcock
    Lebanon, New Hampshire 03766, United States
  • NYU Winthrop
    Mineola, New York 11501, United States
  • NYU Langone Medical Center
    New York, New York 10016, United States
  • Columbia University Medical Center/NYPH
    New York, New York 10032, United States
  • Ohio State University Medical Center
    Columbus, Ohio 43210, United States
  • St. Luke's University Health Network
    Bethlehem, Pennsylvania 18015, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • Seton Heart (Ascension) Univeristy of Austin, Texas
    Austin, Texas 78705, United States
  • University of Alberta
    Edmonton, Alberta, Canada
  • Vancouver General Hospital
    Vancouver, British Columbia V5Z 1M9, Canada
  • St. Boniface General Hospital
    Winnipeg, Manitoba R2H 2A6, Canada
  • University of Calgary
    Calgary, Canada
  • Golden Jubilee National Hospital
    Clydebank, Scotland G81 4DY, United Kingdom
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References and documents

Publications

  • Reynolds HR, Maehara A, Heydari B, Smilowitz NR, Sedlak T, Sandoval Y, Hashim HD, Bainey KR, Fahed AC, Pinilla Echeverri N, Matsumura M, Ahmed M, Saw J, Chong AY, Sharma A, Hausvater A, Xia Y, Tremmel JA, Liu S, Mehta PK, Har B, Bangalore S, Attubato M, Vales Lay L, Holden A, Yu C, Hochman JS; HARP Research Group. Multimodality Imaging to Determine Underlying Causes of Myocardial Infarction With Nonobstructive Coronary Arteries in Women and Men. Circulation. 2026 May 26;153(21):1606-1622. doi: 10.1161/CIRCULATIONAHA.126.080234. Epub 2026 Mar 28. PubMed 41903131 ↗
  • Arabadjian M, Duberstein ZT, Sperber SH, Kaur K, Kalinowski J, Xia Y, Hausvater A, O'Hare O, Smilowitz NR, Dickson VV, Zhong H, Berger JS, Hochman JS, Reynolds HR, Spruill TM. Role of Resilience in the Psychological Recovery of Women With Acute Myocardial Infarction. J Am Heart Assoc. 2023 Apr 18;12(8):e027092. doi: 10.1161/JAHA.122.027092. Epub 2023 Apr 7. PubMed 37026542 ↗
  • Usui E, Matsumura M, Smilowitz NR, Mintz GS, Saw J, Kwong RY, Hada M, Mahmud E, Giesler C, Shah B, Bangalore S, Razzouk L, Hoshino M, Marzo K, Ali ZA, Bairey Merz CN, Sugiyama T, Har B, Kakuta T, Hochman JS, Reynolds HR, Maehara A. Coronary morphological features in women with non-ST-segment elevation MINOCA and MI-CAD as assessed by optical coherence tomography. Eur Heart J Open. 2022 Sep 30;2(5):oeac058. doi: 10.1093/ehjopen/oeac058. eCollection 2022 Sep. PubMed 36225342 ↗
  • Reynolds HR, Kwong RY, Maehara A, Smilowitz NR. Response by Reynolds et al to Letters Regarding Article, "Coronary Optical Coherence Tomography and Cardiac Magnetic Resonance Imaging to Determine Underlying Causes of Myocardial Infarction With Nonobstructive Coronary Arteries in Women". Circulation. 2021 Sep 21;144(12):e209-e210. doi: 10.1161/CIRCULATIONAHA.121.055516. Epub 2021 Sep 20. No abstract available. PubMed 34543066 ↗
  • Reynolds HR, Maehara A, Kwong RY, Sedlak T, Saw J, Smilowitz NR, Mahmud E, Wei J, Marzo K, Matsumura M, Seno A, Hausvater A, Giesler C, Jhalani N, Toma C, Har B, Thomas D, Mehta LS, Trost J, Mehta PK, Ahmed B, Bainey KR, Xia Y, Shah B, Attubato M, Bangalore S, Razzouk L, Ali ZA, Merz NB, Park K, Hada E, Zhong H, Hochman JS. Coronary Optical Coherence Tomography and Cardiac Magnetic Resonance Imaging to Determine Underlying Causes of Myocardial Infarction With Nonobstructive Coronary Arteries in Women. Circulation. 2021 Feb 16;143(7):624-640. doi: 10.1161/CIRCULATIONAHA.120.052008. Epub 2020 Nov 14. PubMed 33191769 ↗

Individual participant data

Plan to share: Yes — De-identified data will be shared after the end of the study.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02905357
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Sep 19, 2016
Start date
Sep 12, 2016
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Mar 19, 2026

Study contacts

Harmony R Reynolds, MD
principal investigator · NYU Langone Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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