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临床试验/NCT00603148
NCT00603148已完成不适用

The Role of Platelet Surface α2β1 Integrin Expression as a Risk Factor in Thrombotic and/or Bleeding Complications in Patients Undergoing Invasive Procedures in the Hybrid Cardiac Catheterization/Cardiac Surgery Suite

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 475 人开始时间: 2006年9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
475
试验地点
1
主要终点
genetic determination of bleeding verses thrombotic risk factors in patients undergoing cardiovascular procedures

研究概览

简要总结

This study will begin to define these critical determinants for patients undergoing procedures in the hybrid interventional cardiology/cardiac surgery suite. In future studies, the data obtained from this study will be used to prospectively stratify patients in terms of bleeding verses thrombotic risk to design studies to optimize anticoagulation and anti-platelet therapies in the hybrid setting.

详细描述

The aim of this study is to test the association of DNA polymorphisms linked to the level of αβ1 integrin expression on platelets with clinical outcome in terms of bleeding or thrombotic complications. The association of polymorphisms in other genes such as GPVI, PAR-1, and COX-2, as well as PLA ½ status, will also be examined and considered in the context of other factors such as medications including IIb/IIIa inhibitors, anticoagulants, type of procedure, obesity smoking status, etc.

Lower levels of platelet surface expression of the α2β1 integrin are associated with an increased risk of bleeding complications following hybrid procedures, especially when the low level of integrin expression is associated with other risk factors that may exacerbate bleeding such as vigorous anti-coagulation, aggressive anti-platelet therapy and other genetic risk factors that contribute to a hemorrhagic phenotype. Conversely, higher level expression of the α2β1 integrin is likely associated with a greater tendency to thrombotic complication that is again modified by other coexisting risk factors.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients will be recruited to the study who are to undergo elective hybrid procedures [percutaneous coronary intervention (PCI) followed by minimally invasive coronary artery bypass graft (CABG) surgery or valve surgery].
  • Both male and females will be enrolled in this study.
  • The age of the population is 18-70 years old.
  • No one ethnic group or gender will be targeted or excluded.

排除标准

  • 未提供

结局指标

主要结局

genetic determination of bleeding verses thrombotic risk factors in patients undergoing cardiovascular procedures

次要结局

未报告次要终点

研究者

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

Samuel A. Santoro

Professor and Chair, Pathology, Microbiology & Immunology

Vanderbilt University

研究点 (1)

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