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Trial record 2 of 4 for:    HARP | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | Gainesville, Florida, U.S.

Women's Heart Attack Research Program- Imaging Study (HARP)

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ClinicalTrials.gov Identifier: NCT02905357
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
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.

Condition or disease Intervention/treatment
Myocardial Infarction Device: OCT Other: CMR

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Women's Heart Attack Research Program- Imaging Study
Actual Study Start Date : August 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MINOCA
OCT and CMR imaging
Device: 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.
Other: CMR
Cardiac Magnetic Resonance Imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (swelling).




Primary Outcome Measures :
  1. Proportion of women with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis) [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Proportion of women with MINOCA who have spontaneous coronary dissection. [ Time Frame: 1 week ]
  2. Proportion of women with MINOCA who have late gadolinium enhancement and/or myocardial edema [ Time Frame: 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. [ Time Frame: 1 week ]
  4. Proportion of patients for whom an etiology can be clearly identified after combining OCT and CMR. [ Time Frame: 1 week ]
  5. Area under curve of clinical prediction model for plaque disruption on OCT in women with MINOCA. [ Time Frame: 1 week ]

Other Outcome Measures:
  1. Composite clinical endpoint: Death, unstable angina, stroke, recurrent MI, catheterizations and revascularization, other cardiac hospitalization. [ Time Frame: 3 years ]
    components of composite will also be examined

  2. Perceived stress [ Time Frame: 1 week ]

Biospecimen Retention:   Samples With DNA
blood collection in platelet substudy


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with MI and no coronary stenosis of 50% or greater on angiography, consecutive.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905357


Contacts
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Contact: Harmony R Reynolds, MD 646-501-0302 harmony.reynolds@nyumc.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: C Noel Bairey Merz, MD         
UC San Diego Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Ehtisham Mahmud, MD         
Stanford University Recruiting
Stanford, California, United States
Contact: Gotzone Garay       ggaray@stanford.edu   
Principal Investigator: Jennifer Tremmel, MD         
United States, Florida
University of Florida Medical Center Recruiting
Gainesville, Florida, United States, 32603
Contact: Ki Park, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Senait Aiser         
Principal Investigator: Puja Kiran Mehta, MD         
United States, Maryland
Johns Hopkins Medical Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jeffrey C Trost, MD         
United States, New Hampshire
Dartmouth-Hitchcock Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Brian J. Aldrich    603-650-6228      
Principal Investigator: Bina Ahmed, M.D.         
United States, New York
NYU Winthrop Recruiting
Mineola, New York, United States, 11501
Contact: Kevin Marzo, MD         
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Harmony R Reynolds, MD    212-263-3627    harmony.reynolds@nyumc.org   
Columbia University Medical Center/NYPH Recruiting
New York, New York, United States, 10032
Contact: Nisha B Jhalani, MD         
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Laxmi Mehta, MD         
United States, Pennsylvania
St. Luke's University Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Thomas Parsons         
Principal Investigator: Dwithiya Thomas, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jenny Whitehead         
Principal Investigator: Catalin Toma, MD         
United States, Texas
Seton Heart (Ascension) Univeristy of Austin, Texas Recruiting
Austin, Texas, United States, 78705
Contact: Virginia Remeny         
Principal Investigator: Caitlin Giesler, MD         
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Norma Hogg       Norma.Hogg@albertahealthservices.ca   
Principal Investigator: Kevin Bainey, MD         
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Tara Sedlak, MD         
Canada
University of Calgary Recruiting
Calgary, Canada
Contact: Rosa Sandonato       Rosa.Sandonato@albertahealthservices.ca   
Principal Investigator: Bryan Har, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Harmony R Reynolds, MD NYU Langone Medical Center

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02905357     History of Changes
Other Study ID Numbers: s16-01104
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared after the end of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Myocardial Infarction
Women
Imaging
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases