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Trial record 1 of 1 for:    NCT02905357
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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
Show Show 17 study locations
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    
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