A Prospective Multicenter Registry on Coronary Function Tests, Organized by the Belgian Working Group on Coronary Microcirculation/Belgian Microcirculation Registry.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 650
- 试验地点
- 13
- 主要终点
- Frequency of coronary microvascular dysfunction and/or coronary artery vasospasm
研究概览
简要总结
The goal of this prospective, multicenter registy is to describe the 'real-world' use of coronary function tests, which may consist of bolus thermodilution measurements of coronary microvascular function and/or invasive vasoreactivity tests with acetylcholine, in the current Belgian routine practice. The main questions it aims to answer are:
- how frequent are coronary function tests performed
- what is the indication for coronary function tests
- what is the frequency of coronary microvascular dysfunction
- what is the frequency of coronary artery vasospasm
From each participant, data will be collected from their medical files concerning cardiovascular risk factors, relevant past medical history, non-invasive tests, procedural data, and follow-up data from routine in-patient visits. Their are no specific study visits. Optionally, patients will be asked to fill in questionnaires about anginal symptoms and quality of life.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for coronary function test, comprising of intracoronary bolus thermodilution measurements of microvascular function, and/or intracoronary vasoreactivity tests with acetylcholine.
- •Subject understands the study requirements and provides written informed consent.
排除标准
- •Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
- •Subject intends to participate in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
- •Documented or suspected pregnancy.
- •Inability to provide written informed consent.
结局指标
主要结局
Frequency of coronary microvascular dysfunction and/or coronary artery vasospasm
时间窗: 5 years
To measure the frequency of coronary microvascular dysfunciton coronary artery and vasomotor disorders among patients undergoing coronary function tests.
次要结局
- Describe predictors for coronary microvascular dysfunction and/or coronary artery vasospasm(5 years)
- Describe 1- year and 3-year MACE among the different endotypes of coronary microvascular dysfunction with/whithout coronary artery spasm.(5 years)