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Trial record 1 of 62 for:    Recruiting Studies | Heart Attack | United States
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Women's Heart Attack Research Program: Platelet Sub-Study (HARP) (HARP)

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ClinicalTrials.gov Identifier: NCT03022552
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date January 13, 2017
First Posted Date January 16, 2017
Last Update Posted Date May 23, 2018
Study Start Date August 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2017)
  • Examination of Platelet Activity Markers [ Time Frame: 1 year ]
  • Examination of Markers of Cardiovascular Disease Risk [ Time Frame: 1 year ]
    This will include additional examination of known thrombosis, Inflammation, metabolic disease, and lipids/lipoprotein markers.
  • Cellular and molecular mechanism of myocardial infarction in women [ Time Frame: 1 year ]
    To further investigate this mechanism, recent advances in microRNA, RNA, DNA expression profiling, and plasma and serum collections will be used.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03022552 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 13, 2017)
Examination of non-coding and coding mRNA profiles in women with MI and matched controls [ Time Frame: 4 years ]
Specific transcripts associated with platelet activation, plaque destabilization, and different cardiovascular diseases will be analyzed at the genetic level.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Women's Heart Attack Research Program: Platelet Sub-Study (HARP)
Official Title Women's Heart Attack Research Program: Platelet Sub-Study (HARP); Platelet Collection for Women With Myocardial Infarction
Brief Summary This prospective observational cohort study, will investigate the platelet phenotype, platelet genetic composition, and role of platelets as effector cells in women with myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at NYU and Bellevue Medical Center, may have concurrent enrollment with the HARP Main Imaging (NCT02914483) and HARP Stress Ancillary Studies (NCT02270359). Additionally, a group of age and race matched disease controls 'CATH-NOCA' composed of women with stable angina referred for cardiac catheterization, will be enrolled. Blood obtained during the initial catheterization, 2 months post-MI, and following the stress study (for those participants enrolled in the stress study) will be utilized for platelet testing.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Retention:   Samples With DNA
Description:
Blood Collection
Sampling Method Non-Probability Sample
Study Population This study may have concurrent enrollment with the HARP Main Imaging (NCT02905357) and HARP Stress Ancillary Studies (NCT02914483). This study population includes women who present to the hospital with an MI, with non-obstructive coronary artery disease or obstructive artery disease, are eligible for blood collection. Additionally, a group of age and race matched disease controls 'CATH-NOCA' will be composed of women with stable angina referred for cardiac catheterization.
Condition Myocardial Infarction
Intervention Not Provided
Study Groups/Cohorts
  • MINOCA
    Women with myocardial infarction (MI) with demonstrated non-obstructive coronary artery disease during cardiac catheterization (less than 50% blockage in any major vessel).
  • MI-CAD
    Women with myocardial infarction (MI) with demonstrated obstructive coronary artery disease during cardiac catheterization (50% or greater blockage in any major vessel) or previous history of percutaneous coronary intervention (PCI) or or coronary artery bypass graft (CABG).
  • CATH-NOCA
    Women with stable angina that are age and race matched to women in the MINOCA arm that are clinically referred for cardiac catheterization
Publications * Barrett TJ, Lee AH, Smilowitz NR, Hausvater A, Fishman GI, Hochman JS, Reynolds HR, Berger JS. Whole-Blood Transcriptome Profiling Identifies Women With Myocardial Infarction With Nonobstructive Coronary Artery Disease. Circ Genom Precis Med. 2018 Dec;11(12):e002387. doi: 10.1161/CIRCGEN.118.002387.

*   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: January 13, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2020
Estimated Primary Completion Date April 2020   (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 (ULN)
    • 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
  • Administration of aspirin at least 1 hour before cardiac catheterization
  • Administration of thienopyridine (e.g., clopidogrel, ticagrelor) at least 1 hour before cardiac catheterization
  • Women with ≥50% of any major epicardial vessel on invasive angiography may participate

Exclusion Criteria:

  • 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
  • Pregnancy
  • Thrombolytic therapy for STEMI (qualifying event)
  • Use of any of the following medications:
  • Platelet antagonists (except aspirin and thienopyridines) within 7 days
  • NSAIDs (e.g., ibuprofen, naproxen) within 3 days.
  • Thrombocytopenia (platelet count <100,000)
  • Thrombocytosis (platelet count >500,000)
  • Anemia (hemoglobin <9 mg/dl)
  • Hemorrhagic diathesis
Sex/Gender
Sexes Eligible for Study: Female
Ages 21 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jeffrey Berger, MD 212 263 4004 jeffrey.berger@nyumc.org
Contact: Harmony R Reynolds, MD 646-501-0302 harmony.reynolds@nyumc.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03022552
Other Study ID Numbers 16SFRN28730002
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 May 2018