The NetherLands Registry of Invasive Coronary Vasomotor Function Testing (NL-CFT)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,000
- 试验地点
- 15
- 主要终点
- Prevalence of coronary vasomotor dysfunction
研究概览
简要总结
The goal of this registry is to collect data on patients referred for clinically indicated coronary vasomotor function test (CFT) and answer different questions on prevalence, safety and outcomes. The registry is observational. Patients receive yearly online questionnaires on their anginal complaints for 5 years after their CFT.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for clinically indicated CFT
排除标准
- •Not willing to provide informed consent
结局指标
主要结局
Prevalence of coronary vasomotor dysfunction
时间窗: Baseline
Can be handled as dichotomous outcome with normal vs abnormal coronary function test (CFT) results. Alternatively, can also be handled as categorical outcome with the following categories. 1. Normal CFT results 2. Vasospastic endotype (epicardial or microvascular); tested by acetylcholine provocation 3. Microvascular dysfunction endotype (decreased coronary flow reserve or increased index of microvascular resistance); tested by bolus thermodilution, optionallly with additional continuous thermodilution method 4. Mixed endotype
次要结局
- Angina burden(Baseline and every year up to 5 years after baseline)
- Experienced quality of life(Baseline and every year up to 5 years after baseline)