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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINOCA | OCT and CMR imaging |
| |
| MI-CAD | Screen failures with MI found to have obstructive CAD. Limited data collection for comparison to MINOCA cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT | Device | Optical Coherence Tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis) | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Composite clinical endpoint: Death, unstable angina, stroke, recurrent MI, catheterizations and revascularization, other cardiac hospitalization. | components of composite will also be examined | 10 years |
| Perceived stress |
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):
Willing to provide informed consent and comply with all aspects of the protocol
Age ≥ 21 years
Exclusion Criteria:
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Men and women with MI and no coronary stenosis of 50% or greater on angiography, consecutive.
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| Name | Affiliation | Role |
|---|---|---|
| Harmony R Reynolds, MD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama-Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Cedars-Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41903131 | Derived | 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. | |
| 37026542 |
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De-identified data will be shared after the end of the study.
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blood collection in platelet substudy
| CMR | Other | Cardiac Magnetic Resonance Imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (swelling). |
|
| 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 |
| 1 week |
| 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 |
| Derived |
| 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. |
| 36225342 | Derived | 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. |
| 34543066 | Derived | 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. |
| 33191769 | Derived | 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. |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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