跳至主要内容
临床试验/NCT04450459
NCT04450459已完成不适用

Impact of Ergospirometric Oxygen Uptake Under Exercise as Diagnostic Marker of Cardiac Ischemia in Patients With Stable Angina Compared to Non Invasive and Invasive (FFR) Measurement of Ischemia

Jena University Hospital2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2019年1月2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
121
试验地点
2
主要终点
double slope sign of ΔV̇O2/ΔWR-Increase

研究概览

简要总结

In Patients with stable Angina pectoris CCS 1-3 exercise testing for ischemia detection is widely used despite the known limitations. Measurement of the FFR is invasive but gold standard for Ischemia detection.

Adding of parameters of spiroergometer might help to improve diagnostic accuracy of non invasive exercise testing. Therefore the trial is evaluating diagnostic accuracy of spiroergometric parameters compared to invasive FFR measurement.

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

  • stable Angina (CCS >1-3) with suspected CAD or
  • dyspnoea at exertion NYHA >2 or
  • signs of ischemia within SPECT or exercise electrocardiography
  • willingness to participate in the trial

排除标准

  • Unstable angina or myocardial infarction within the last 2 weeks
  • inability to perform bicycle exercise test
  • significant valvular disease
  • av- block >I degree
  • asthma bronchiales

结局指标

主要结局

double slope sign of ΔV̇O2/ΔWR-Increase

时间窗: baseline

double slope sign of ΔV̇O2/ΔWR by ergospirometer test

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 (2)

Loading locations...

相似试验