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临床试验/NCT01417884
NCT01417884招募中不适用

Development of a Prospective Cardiovascular Patient Cohort and Biobank and Provision of Genomic Analyses With Focus on Platelet Function and Platelet Mediated Inflammatory Processes

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
1
主要终点
Mortality

研究概览

简要总结

Molecular targets on platelets are pivotal for the development of new pharmacological substrates for platelet inhibition and to better understand the impact of platelet-mediated inflammatory processes for the progression of heart disease, such as coronary heart disease and chronic heart failure. Previous investigations on the thienopyridine Clopidogrel have underlined the importance of combined risk factor analysis. Thus, clopidogrel´s prognostic efficacy relies on the combination of genetic factors (mainly polymorphisms of CYP2C19 encoding genes) and non-genetic factors, such as age, diabetes mellitus or concomitant drugs. Therefore, a prospective patient cohort with exact phenotypic characterisation according to standardized protocols is necessary to enable the examination of the clinical relevance of potential molecular targets. A supplementary provision of high quality bio-material enables the systematic examination of new promising platelet-biomarkers in cardiovascular disease, which already have produced significant results on experimental animal and/or cell biologic models. Primary objective of the central project is to establish a prospective cardiological cohort in the setting of a Cardiovascular Clinical Research Unit (CCRU) with an affiliated Biobank and thus to review the clinical significance of potential targets deriving from individual subprojects within the research group (German Research Council KFO 274/1-1) to safeguard a translational approach.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with ischemic and non-ischemic heart disease
  • informed consent by patients or relatives in case of missing capacity to consent due to health status

排除标准

  • Patients <18 years
  • missing informed consent

结局指标

主要结局

Mortality

时间窗: 4 years

次要结局

  • ischemic stroke(4 years)
  • bleeding(4 years)
  • stent thrombosis(4 years)
  • Myocardial infarction(4 years)
  • Cardiovascular Death(4 years)

研究者

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

Prof. Dr. Tobias Geisler

Deputy Director

University Hospital Tuebingen

研究点 (1)

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