跳至主要内容
临床试验/NCT02137980
NCT02137980已完成不适用

Registry of Non-primary Angioplasty at Hospitals Without Surgery On-site

Johns Hopkins University37 个研究点 分布在 1 个国家目标入组 31,390 人开始时间: 2011年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31,390
试验地点
37
主要终点
Number of participants with adverse events

研究概览

简要总结

This is a simple registry of patients undergoing PCI at hospitals without surgery on-site who were participants in the CPORT-E project. The aim of the registry is simple data collection and reporting to respective State Departments of Health. The registry population consists of patients undergoing diagnostic cardiac catheterization for suspected CAD at hospitals without SOS and who require PCI.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient inclusion criteria are:
  • Pre-catheterization
  • must be undergoing diagnostic cardiac catheterization for suspected CAD
  • be at least 18 years of age
  • must not be pregnant (negative pregnancy test) or must not be of childbearing potential
  • must be able to give informed consent. Post-catheterization
  • coronary artery disease judged to be clinically and angiographically significant
  • ability to perform PCI with equipment available at the local site (see below)
  • procedure risk judged to be not high (see below)

排除标准

  • Patient exclusion criteria are:
  • Pre-catheterization
  • inability to give informed consent
  • ST-segment elevation myocardial infarction
  • pregnancy Post-catheterization
  • high likelihood of requiring a device not available at the hospitals without SOS (see below)
  • no need for PCI
  • need for coronary artery bypass surgery
  • high procedural risk (see below)

结局指标

主要结局

Number of participants with adverse events

时间窗: Thru Index or Transfer Hospital Discharge on average 24 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (37)

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