NCT05805462进行中（未招募）不适用
European microCirculatory Resistance and Absolute Flow Team: The Euro-CRAFT Registry
CoreAalst BV19 个研究点 分布在 8 个国家目标入组 671 人开始时间: 2022年9月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 671
- 试验地点
- 19
- 主要终点
- The rate of MACCE between patients with and without CMD based on MRR at 1-year follow-up.
研究概览
简要总结
The Euro-CRAFT Registry is a prospective, multicentric, international registry of patients undergoing functional assessment of the coronary microcirculation using the continuous thermodilution technique. Angina and quality of life questionnaires (Seattle Angina Questionnaire 19 - SAQ19, ORBITA app) will be obtained at baseline, at 6 months, and 1-year follow-up. Clinical follow-up will be performed at 1 year (optionally until 5 years).
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
- 否
入选标准
- •Age > 18 years.
- •Stable patients should have complaints of chest pain suspected of angina pectoris or other symptoms raising the suspicion of IHD and non-obstructive epicardial coronary arteries on invasive coronary angiography (ICA, diameter stenosis of less than 50%) with an FFR >0.
- •Any other clinical scenario (including in the context of ACS) prompting the physician to assess the function of the coronary microvasculature.
排除标准
- •Unable to provide consent
- •Unstable hemodynamics
- •Ongoing chest pain.
- •Previous CABG
- •Moderate to severe valvular heart disease
- •Uncontrolled or recurrent ventricular tachycardia.
- •Active liver disease or hepatic dysfunction, defined as AST or ALT > 3 times the ULN.
- •Comorbidity with life expectancy <= 2 years.
- •Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m
- •Subject is currently participating in another investigational drug or device clinical study.
- •Presence of other anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
结局指标
主要结局
The rate of MACCE between patients with and without CMD based on MRR at 1-year follow-up.
时间窗: 12 months follow-up
Rate of Major Adverse Cardiac and Cerebrovascular Events at one year (MACCE defined as cardiovascular death, angina and heart failure related hospitalisations and stroke) between patients with and without Coronary Microvascular Disease (CMD) defined according to thermodilution derived metrics (Microvascular Resistance Reserve, MRR).
次要结局
- Relationship between MACCE's and each thermodilution- derived metrics of microvascular function(12 months follow-up)
- Relationship between the presence and severity of angina, assessed by SAQ- 19, and each individual thermodilution-derived metrics of microvascular function(12 months follow-up)
- Relationship between the presence and severity of angina, assessed by the ORIBTA Euro-CRAFT app, and each individual thermodilution-derived metrics of microvascular function(12 months follow-up)
- Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration.(12 months follow-up)
- To determine cut-off values of thermodilution-derived indices(12 months follow-up)
- To assess the prevalence of Coronary Microvascular Disease based on Microvascular Resistance Reserve in patients with angina and non-obstructive coronary artery disease (NOCAD)(12 months follow-up)
研究者
研究点 (19)
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