Women's Heart Attack Research Program- Imaging Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 99
Updated:3/23/2019
Start Date:August 2016
End Date:April 2020
Contact:Harmony R Reynolds, MD
Email:harmony.reynolds@nyumc.org
Phone:646-501-0302

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The Women's HARP study is a multi-center, diagnostic observational study employing
standardized imaging protocols in women 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 3 years.

Women's HARP is a multi-center, observational study which enrolls 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- Stress Ancillary Study and
HARP-Platelet Sub-Study.

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

- Female sex

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)
We found this trial at
14
sites
Bethlehem, Pennsylvania
Principal Investigator: Dwithiya Thomas, MD
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Puja Kiran Mehta, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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Baltimore, Maryland 21231
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Baltimore, MD
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Austin, Texas 78705
Principal Investigator: Caitlin Giesler, MD
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Austin, TX
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Columbus, OH
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Gainesville, Florida 32610
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Gainesville, FL
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Lebanon, New Hampshire 03756
Principal Investigator: Bina Ahmed, M.D.
Phone: 603-650-6228
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Lebanon, NH
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259 1st Street
Mineola, New York 11501
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Mineola, NY
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New York, New York 10016
Phone: 212-263-3627
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New York, NY
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New York, NY
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Catalin Toma, MD
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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San Diego, California 92103
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Vancouver, British Columbia
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Vancouver,
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