Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2020-07-01
2026-06-30
Brief Summary
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Detailed Description
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Participants will also have the option to enroll in the HARP-Platelet Sub-Study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MINOCA
OCT and CMR imaging
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.
CMR
Cardiac Magnetic Resonance Imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (swelling).
Interventions
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OCT
Optical Coherence Tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.
CMR
Cardiac Magnetic Resonance Imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (swelling).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
21 Years
99 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Harmony R Reynolds, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Medical Center
Locations
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University of Alabama-Birmingham
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UC San Diego Medical Center
San Diego, California, United States
Stanford University
Stanford, California, United States
University of Florida Medical Center
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
Johns Hopkins Medical Center
Baltimore, Maryland, United States
Dartmouth-Hitchcock
Lebanon, New Hampshire, United States
NYU Winthrop
Mineola, New York, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Ohio State University Medical Center
Columbus, Ohio, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Seton Heart (Ascension) Univeristy of Austin, Texas
Austin, Texas, United States
University of Alberta
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
University of Calgary
Calgary, , Canada
Countries
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Central Contacts
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Facility Contacts
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Wendy Drewes
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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16-01104-2
Identifier Type: -
Identifier Source: org_study_id
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