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临床试验/NCT02241291
NCT02241291招募中不适用

CARDIOBASE Bern PCI Registry

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2009年3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
10,000
试验地点
1
主要终点
Number of patients with death

研究概览

简要总结

The aim of the CARDIOBASE Bern PCI registry is to collect baseline clinical and procedural data as well as to assess the clinical outcomes of all patients undergoing percutaneous coronary intervention (PCI) at Bern University Hospital. All patients undergoing PCI with or without stent implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry. At hospital discharge and one year, the following outcomes will be assessed: death, cardiac death, myocardial infarction, stent thrombosis, repeat revascularisation, stent thrombosis, stroke, bleeding, renal failure and vascular complications.

详细描述

Background

Percutaneous Coronary Intervention (PCI) is the most frequently medical intervention performed worldwide. Coronary heart disease (CAD) remains the leading cause of death, although advances in the management of acute myocardial infarction (MI) have reduced in-hospital mortality from 16% in the mid-1980s to around 4 to 6%. Several breakthroughs have accounted for improvement of cardiovascular outcomes, including the use and further improvement of coronary stents and antiplatelet therapy. Regarding stents, bare metal stents were first introduced but associated with a high risk of restenosis, something which was successfully addressed by the introduction of drug-eluting stents.

All benefits and shortcomings of newly introduced devices and drug therapies are evaluated in large randomized controlled trials (RCT). Registries provide useful insights into novel associations that cannot be addressed by RCT.

The aim of the CARDIOBASE Bern PCI registry is to collect baseline clinical and procedural data as well as to assess the clinical outcomes of all patients undergoing percutaneous coronary intervention at Bern University Hospital. All patients undergoing PCI with or without stent implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.

Objective

研究设计

研究类型
Observational
观察模型
Other
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

  • Patient above 18 years of age
  • Undergoing PCI at Bern University Hospital
  • Written informed consent
  • Exclusion Criteria
  • No informed consent

排除标准

  • 未提供

结局指标

主要结局

Number of patients with death

时间窗: At discharge, expected to be on average after 2 days, & at one year

次要结局

  • Number of patients with myocardial infarction(At discharge, expected to be on average after 2 days, & at one year)
  • Number of patients with stent thrombosis(At discharge, expected to be on average after 2 days, & at one year)
  • Number of patients with stroke(At discharge, expected to be on average after 2 days, & at one year)
  • Number of patients with(At discharge, expected to be on average after 2 days, & at one year)
  • Number of patients with repeat revascularisation(At discharge, expected to be on average after 2 days, & at one year)
  • Number of patients with bleeding(At discharge, expected to be on average after 2 days, & at one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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