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Myocardial InfarctionHARPNCT02905357

Heart Attack Research Program- Imaging Study

An observational study of Myocardial Infarction, run by NYU Langone Health at 20 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 99 years
Conditions the study is for
Myocardial Infarction
What is being tested?
OCT and CMR
Type of treatment
Medical device
How many people
450 participants
Where
20 sitesin 3 countries
Study dates
12 Sep 2016to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

20 sites in 3 countries.

20 sites in 3 countries

United States15 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Seton Heart (Ascension) Univeristy of Austin, Texas

    Austin, Texas, 78705

  • Johns Hopkins Medical Center

    Baltimore, Maryland, 21287

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015

  • University of Alabama-Birmingham

    Birmingham, Alabama, 35294

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • University of Florida Medical Center

    Gainesville, Florida, 32603

  • Dartmouth-Hitchcock

    Lebanon, New Hampshire, 03766

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • NYU Winthrop

    Mineola, New York, 11501

  • NYU Langone Medical Center

    New York, New York, 10016

  • Columbia University Medical Center/NYPH

    New York, New York, 10032

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • UC San Diego Medical Center

    San Diego, California, 92103

  • Stanford University

    Stanford, California, 94305

Other trials in United States

Canada4 sites

  • University of Calgary

    Calgary

  • University of Alberta

    Edmonton, Alberta

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

United Kingdom1 site

  • Golden Jubilee National Hospital

    Clydebank, Scotland, G81 4DY

Other trials in United Kingdom

About this study

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.

Being tested
OCT, CMR
Keywords
Myocardial Infarction, Imaging
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OCTDevice

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

  • CMROther

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

Study groups in NCT02905357
Study groupRoleWhat they receive
MINOCAOCT and CMR imaging
Receives: Device: OCT
MI-CADScreen failures with MI found to have obstructive CAD. Limited data collection for comparison to MINOCA cohort.
Receives: Other: CMR

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 week

Secondary outcomes (5)

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

    Measured: 1 week

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

    Measured: 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.

    Measured: 1 week

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

    Measured: 1 week

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

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2016 (estimated)
  2. Study start12 Sep 2016
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02905357
Sponsor's protocol ID
16-01104-2
Acronym
HARP
Status last verified
Mar 2026
First submitted
9 Sep 2016
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be shared after the end of the study.

Publications

  • Shwayder EM, Li V, Serrano Gomez C, Shah B, Elbaum L, Hochman JS, Hausvater A, Maehara A, Matsumura M, Sedlak T, Saw J, Yu C, Reynolds HR, Smilowitz NR. Accuracy of Angiographic Identification of Culprit Lesions in Women With MINOCA. Circ Cardiovasc Interv. 2026 Sep 10:e016979. doi: 10.1161/CIRCINTERVENTIONS.126.016979. Online ahead of print.

    PubMed 42717865

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction, run by NYU Langone Health at 20 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis) (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02905357, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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