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Trial record 2 of 2 for:    HARP | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | Gainesville, Florida, U.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 : August 12, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date September 9, 2016
First Posted Date September 19, 2016
Last Update Posted Date August 12, 2021
Actual Study Start Date July 1, 2020
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 15, 2020)
Proportion of patients with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis) [ Time Frame: 1 week ]
Original Primary Outcome Measures
 (submitted: September 13, 2016)
Proportion of women with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis) [ Time Frame: 1 week ]
Change History
Current Secondary Outcome Measures
 (submitted: September 15, 2020)
  • Proportion of patients with MINOCA who have spontaneous coronary dissection. [ Time Frame: 1 week ]
  • Proportion of patients with MINOCA who have late gadolinium enhancement and/or myocardial edema [ Time Frame: 1 week ]
  • 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 ]
  • Proportion of patients for whom an etiology can be clearly identified after combining OCT and CMR. [ Time Frame: 1 week ]
  • Area under curve of clinical prediction model for plaque disruption on OCT in patients with MINOCA. [ Time Frame: 1 week ]
Original Secondary Outcome Measures
 (submitted: September 13, 2016)
  • Proportion of women with MINOCA who have spontaneous coronary dissection. [ Time Frame: 1 week ]
  • Proportion of women with MINOCA who have late gadolinium enhancement and/or myocardial edema [ Time Frame: 1 week ]
  • 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 ]
  • Proportion of patients for whom an etiology can be clearly identified after combining OCT and CMR. [ Time Frame: 1 week ]
  • Area under curve of clinical prediction model for plaque disruption on OCT in women with MINOCA. [ Time Frame: 1 week ]
Current Other Pre-specified Outcome Measures
 (submitted: September 15, 2020)
  • Composite clinical endpoint: Death, unstable angina, stroke, recurrent MI, catheterizations and revascularization, other cardiac hospitalization. [ Time Frame: 10 years ]
    components of composite will also be examined
  • Perceived stress [ Time Frame: 1 week ]
Original Other Pre-specified Outcome Measures
 (submitted: September 13, 2016)
  • 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
  • Perceived stress [ Time Frame: 1 week ]
 
Descriptive Information
Brief Title Heart Attack Research Program- Imaging Study
Official Title Heart Attack Research Program- Imaging Study
Brief Summary 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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood collection in platelet substudy
Sampling Method Non-Probability Sample
Study Population Men and women with MI and no coronary stenosis of 50% or greater on angiography, consecutive.
Condition Myocardial Infarction
Intervention
  • Device: OCT
    Optical Coherence Tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.
  • Other: CMR
    Cardiac Magnetic Resonance Imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (swelling).
Study Groups/Cohorts
  • MINOCA
    OCT and CMR imaging
    Intervention: Device: OCT
  • MI-CAD
    Screen failures with MI found to have obstructive CAD. Limited data collection for comparison to MINOCA cohort.
    Intervention: Other: CMR
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 15, 2020)
450
Original Estimated Enrollment
 (submitted: September 13, 2016)
500
Estimated Study Completion Date June 30, 2025
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Eligibility 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

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Harmony R Reynolds, MD 646-501-0302 harmony.reynolds@nyumc.org
Listed Location Countries United States,   Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02905357
Other Study ID Numbers s16-01104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared after the end of the study.
Responsible Party NYU Langone Health
Study Sponsor NYU Langone Health
Collaborators Not Provided
Investigators
Principal Investigator: Harmony R Reynolds, MD NYU Langone Medical Center
PRS Account NYU Langone Health
Verification Date August 2021