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临床试验/NCT02505217
NCT02505217已完成不适用

Novel Biomarkers of Thrombotic Risk

University of Vermont1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Cardiovascular Event - Myocardial Infarction, Stroke, Death

研究概览

简要总结

Treatment of patients who have had a heart attack with drugs that prevent formation of blood clots has been shown to reduce the patient's risk of subsequent cardiovascular events such as heart attack, stroke, and death. Because new drugs have increased treatment options, the development of tests that can guide treatment should improve treatment selection and further reduce the risk of cardiovascular events as well as bleeding. This study is designed to assess the value of new tests. It is a prospective study that will enroll patients who have had a heart attack. Blood will be taken during hospitalization for a heart attack (1 day after their heart attack) and a second time 6 months later during an ambulatory clinical visit. Investigators will perform biochemical tests on the blood that assess the likelihood of making blood clots. One tablespoon of blood will be taken at each time. Taking this amount of blood poses no risk to the participant. Investigators will ask the participant whether they have had bleeding or cardiovascular events during the initial evaluation, the ambulatory follow-up at 6 months, and during a telephone interview 1 year after enrollment. During their 1 year of participation, investigators will review medical records and record information in a manner that protects the identity of all participants. We hypothesize that the biochemical test results will be similar at baseline and 6 month follow-up and that these biochemical tests will identify patients at greater risk of cardiovascular events and bleeding. Treatment of participants will not be altered by their participation in this study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Myocardial infarction demonstrated by elevated markers of cardiac injury (troponin I (TNI) or creatine kinase (CK) MB fraction)
  • the presence of coronary artery disease demonstrated by cardiac catheterization or perfusion imaging

排除标准

  • Treatment with long term anticoagulants
  • active infection
  • malignancy

结局指标

主要结局

Cardiovascular Event - Myocardial Infarction, Stroke, Death

时间窗: average duration of follow-up 19 months

number of participants with myocardial infarction, stroke, and/or death

次要结局

  • Bleeding(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David J. Schneider, MD

Professor of Medicine

University of Vermont

研究点 (1)

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