NCT02905357

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
3 countries

20 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Sep 2016Jun 2027

First Submitted

Initial submission to the registry

September 9, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

September 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

10.8 years

First QC Date

September 9, 2016

Last Update Submit

March 18, 2026

Conditions

Myocardial Infarction

Keywords

Myocardial InfarctionImaging

Outcome Measures

Primary Outcomes (1)

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

    1 week

Secondary Outcomes (5)

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

    1 week

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

    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.

    1 week

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

    1 week

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

    1 week

Other Outcomes (2)

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

    10 years

  • Perceived stress

    1 week

Study Arms (2)

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

OCTDEVICE

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

MINOCA
CMROTHER

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

MI-CAD

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UC San Diego Medical Center

San Diego, California, 92103, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Florida Medical Center

Gainesville, Florida, 32603, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03766, United States

Location

NYU Winthrop

Mineola, New York, 11501, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Seton Heart (Ascension) Univeristy of Austin, Texas

Austin, Texas, 78705, United States

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

University of Calgary

Calgary, Canada

Location

Golden Jubilee National Hospital

Clydebank, Scotland, G81 4DY, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 37026542DERIVED

  • 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.

    PMID: 36225342DERIVED

  • 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.

    PMID: 34543066DERIVED

  • 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.

    PMID: 33191769DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood collection in platelet substudy

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Harmony R Reynolds, MD

    NYU Langone Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 19, 2016

Study Start

September 12, 2016

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Locations

CA(4)US(15)GB(1)