Clinical trial NCT03022552: Heart Attack Research Program: Platelet Sub-Study (HARP)
Official title: Heart Attack Research Program: Platelet Sub-Study (HARP); Platelet Collection for Patients With Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Keywords: Myocardial Infarction
Platelets
Blood Collection
Genomics
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 350
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study may have concurrent enrollment with the HARP Main Imaging (NCT02905357). This study population includes women and men 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 sex, group of age and race matched disease controls 'CATH-NOCA' will be composed of women and men with stable angina referred for cardiac catheterization.

Brief summary: This prospective observational cohort study, will investigate the platelet phenotype, platelet genetic composition, and role of platelets as effector cells in women and men with myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at NYU and Bellevue Medical Center, and participating external sites. May have concurrent enrollment with the HARP Main Imaging (NCT02914483). Additionally, a sex, group of age and race matched disease controls 'CATH-NOCA' composed of women and men with stable angina referred for cardiac catheterization, will be enrolled. Blood obtained during the initial catheterization and 2 months post-MI will be utilized for platelet testing.


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
* 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 and men 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

Primary outcomes:
measure: Examination of Platelet Activity Markers
timeFrame: 1 year
measure: Examination of Markers of Cardiovascular Disease Risk
timeFrame: 1 year
measure: Cellular and molecular mechanism of myocardial infarction in women
timeFrame: 1 year
Secondary outcomes:
measure: Examination of non-coding and coding mRNA profiles in women with MI and matched controls
timeFrame: 4 years
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Harmony R Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barrett TJ, Corr EM, van Solingen C, Schlamp F, Brown EJ, Koelwyn GJ, Lee AH, Shanley LC, Spruill TM, Bozal F, de Jong A, Newman AAC, Drenkova K, Silvestro M, Ramkhelawon B, Reynolds HR, Hochman JS, Nahrendorf M, Swirski FK, Fisher EA, Berger JS, Moore KJ. Chronic stress primes innate immune responses in mice and humans. Cell Rep. 2021 Sep 7;36(10):109595. doi: 10.1016/j.celrep.2021.109595.
citation: 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. No abstract available.