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临床试验/NCT04485234
NCT04485234已完成不适用

Inclusive Invasive Physiological Assessment in Angina Syndromes Registry (ILIAS Registry)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)12 个研究点 分布在 7 个国家目标入组 2,322 人开始时间: 2019年6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
2,322
试验地点
12
主要终点
Major adverse cardiac events

研究概览

简要总结

This study evaluates the prognostic value and potential therapeutic impact of combined pressure and flow measurements in the evaluation of epicardial coronary stenosis and microvascular function.

详细描述

ILIAS registry is a global effort to gather lesion-level data on the diagnostic and prognostic value of combined coronary pressure and flow measurements in clinical practice. Data is gathered from 7 nations (The Netherlands, Korea, Japan, Spain, Italy, Denmark, USA), using either coronary Doppler velocity measurements or coronary thermodilution measurements to obtain invasive coronary flow assessment. Patient treatment was governed by the local clinical practice guidelines at the time of the invasive procedure, but was at the operator's discretion. A standardized data collection sheet was used and all study adopted standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data. In case of acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction), only non-culprit vessel evaluation was used.

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

  • underwent combined measurements of coronary pressure and flow for at least 1native coronary artery

排除标准

  • hemodynamic instability
  • culprit vessel of acute coronary syndrome

结局指标

主要结局

Major adverse cardiac events

时间窗: 10 years

Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization

次要结局

  • Individual components of MACE and TVF(10 years)
  • Target vessel failure(10 years)

研究者

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

Tim van de Hoef

M.D., Ph.D.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (12)

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