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临床试验/NCT03671356
NCT03671356已完成不适用

Risk Management in Interventional Cardiology - a Quality Management Single-center Registry

Heinrich-Heine University, Duesseldorf1 个研究点 分布在 1 个国家目标入组 2,067 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,067
试验地点
1
主要终点
mortality

研究概览

简要总结

The validity and applicability of different clinical risk scoring models in a variety of settings of interventional cardiology is evaluated in a retrospective and continuing prospective single-center registry at University Hospital Düsseldorf. Risk-adapted safety interventions are additionally tested.

详细描述

Beginning with a retrospective assessment of 2014-2017 and continuing with a prospective registry, clinical outcomes of interventional cardiac catheterization procedures at University Hospital Düsseldorf in a variety of settings (elective and emergency coronary procedures, structural and rhythmologic cardiac interventions etc.), will be evaluated. Different risk scoring models are recommended for risk stratification by cardiovascular societies (e.g. GRACE, CRUSADE, NCDR, ACEF, EUROScore scores) and will be evaluated for their applicability to contemporary and local clinical practice in interventional cardiology. Risk-adapted safety interventions (e.g. intensified monitoring, vascular access closure, renal protective measures) will be applied to all patients and will be evaluated for their impact on clinical outcomes.

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

  • >18 yeas of age, written informed consent, cardiac catheterization at university hospital Düsseldorf, Germany

排除标准

  • no written informed consent

结局指标

主要结局

mortality

时间窗: 30 days

In-hospital mortality will be assessed and primarily reported

次要结局

  • Bleeding (according to BARC bleeding definition)(30 days and up to 5 years post procedure)
  • TIA and Stroke(30 days and up to 5 years post procedure)
  • Acute and chronic kidney injury (according to KDIGO definitions)(30 days and up to 5 years post procedure)
  • Quality of life (assessed by standardized QoL surveys)(30 days and up to 5 years post procedure)
  • Long-term mortality(up to 5 years post procedure)

研究者

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Sponsor

研究点 (1)

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