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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

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.

Condition or disease
Myocardial Infarction

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Women's Heart Attack Research Program: Platelet Sub-Study (HARP); Platelet Collection for Women With Myocardial Infarction
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

MedlinePlus related topics: Heart Attack

Group/Cohort
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



Primary Outcome Measures :
  1. Examination of Platelet Activity Markers [ Time Frame: 1 year ]
  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood Collection


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:   Yes
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.
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

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): NCT03022552


Contacts
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Contact: Jeffrey Berger, MD 212 263 4004 jeffrey.berger@nyumc.org
Contact: Harmony R Reynolds, MD 646-501-0302 harmony.reynolds@nyumc.org

Locations
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United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Jeffrey Berger, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Harmony R Reynolds, MD NYU Langone Medical Center

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03022552     History of Changes
Other Study ID Numbers: 16SFRN28730002
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
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
Platelets
Blood Collection
Genomics
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases