CompREhensive Diagnostic Assessment of Coronary Endothelial Function Impairment and Vasospasm With CoNtinuous ThErmodilution in Patients With Suspected Coronary Microvascular and Vasomotor Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Feasibility outcome
研究概览
简要总结
The goal of this observational study is to learn more about the diagnosis of coronary endothelium function and coronary vasospasm using a dedicated invasive protocol in patients who has angina without obstruction in their main heart arteries. The main question it aims to answer is the feasibility, reproducibility, and safety of this invasive protocol:
Does this invasive protocol diagnose coronary endothelial dysfunction and vasospasm without issues?
Participants already having invasive coronary angiogram and physiological studies will undergo additional physiological measurements during the same procedure.
Participants will enrol in a symptoms and quality of life questionnaire using dedicated questionnaires and a mobile application to assess the burden of their symptoms before and after the invasive procedure and up to 12 months follow up.
A subset of participants will undergo a repeat set of these measurements to assess reproducibility of the invasive protocol.
A subset of the participants will also undergo a cardiac MRI to assess correlation with the invasive protocol measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients with symptoms suggestive of angina.
- •Evidence of unobstructed coronary arteries on invasive or non-invasive coronary angiography (coronary stenosis <50% and /or FFR >0.80).
- •Above the age of
- •The subject has been informed of the nature of the study, agrees to its provisions and has signed written informed consent.
排除标准
- •Contraindication to angiography and/or physiological assessment with adenosine or acetylcholine.
- •Previous coronary artery bypass graft (CABG).
- •Moderate to severe valvular heart disease.
结局指标
主要结局
Feasibility outcome
时间窗: At baseline
Proportion of patients in whom the full invasive protocol (baseline and post-stimulation measurements) is successfully completed without major technical issues or protocol deviations.
次要结局
- Reproducibility outcome(At baseline)
- Safety outcome(At Baseline and up to 12 months)
- Correlation between invasive and non-invasive measures of endothelial-dependent coronary microvascular dysfunction.(From baseline and up to 3 months)
- Correlation between invasive physiological indices of coronary microvascular function and symptom burden at baseline.(Baseline (at time of invasive coronary function testing).)
- Change in symptoms, quality of life, and need for further investigation or treatment during follow-up.(From baseline to 12 months follow-up)