Heart Attack Research Program: Platelet Sub-Study (HARP); Platelet Collection for Patients With Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Cellular and molecular mechanism of myocardial infarction in women
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
结局指标
主要结局
Cellular and molecular mechanism of myocardial infarction in women
时间窗: 1 year
To further investigate this mechanism, recent advances in microRNA, RNA, DNA expression profiling, and plasma and serum collections will be used.
Examination of Platelet Activity Markers
时间窗: 1 year
Examination of Markers of Cardiovascular Disease Risk
时间窗: 1 year
This will include additional examination of known thrombosis, Inflammation, metabolic disease, and lipids/lipoprotein markers.
次要结局
- Examination of non-coding and coding mRNA profiles in women with MI and matched controls(4 years)