Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease (EndoFIND Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Total incidence number of Major Adverse Cardiovascular Events
研究概览
简要总结
The purpose of this study is to systematically evaluate the clinical application value of vascular endothelial function examination in patients with non-obstructive coronary artery disease.
详细描述
The study will be carried out in two stages. Phase I is mainly intended to evaluate the effects of vascular EFT on the prescription of doctors and the application rate of mid and long-term secondary prevention medication in patients. If the results are positive, the sample size and observation time will be further expanded in Phase II to evaluate its impact on the cardiovascular events of patients, as well as its cost-effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This study is patient and assessor blinded; that is, both groups of patients are unaware of the endothelial function results. This study will use blind methods for endpoint data collectors; that is, the data collectors will collect secondary prevention medication and cardiovascular event data for coronary artery disease without an awareness of patient grouping.
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 or older;
- •Patients with NOCAD defined by CT or CAG results of less than 50% occlusion;
- •Having signed their written informed consent.
排除标准
- •Left ventricular ejection fraction ≤ 50%;
- •Serious endocrine diseases (severe hyperthyroidism, hypothyroidism);
- •Severe liver diseases (jaundice hepatitis, liver cirrhosis, liver failure);
- •Severe nephropathy (uremia, renal failure);
- •Severe inflammatory diseases (severe infection, lupus erythematosus, etc.);
- •Malignant tumor;
- •Mental disorders or cognitive disorders;
- •Participating in other interventional clinical trials;
- •There are any other factors that the treating doctors think are not suitable for inclusion or completion of this study.
结局指标
主要结局
Total incidence number of Major Adverse Cardiovascular Events
时间窗: up to 54 months
The incidence number of MACE(Major Adverse Cardiovascular Events) including total death, non-fatal AMI or stroke(including stroke revascularization).
Compliance rate of patients to physicians prescription
时间窗: up to 30 months
The incidence number of patients compliance to guidelines based medical therapy with prescription of cholesterol, blood pressure and glucose lowering medications by physicians at clinic for patients with non-obstructive coronary artery disease.
次要结局
- Mean improvement of endothelial function(up to 30 months)
- Incidence number of Major Adverse Cardiovascular Events(up to 30 months)
- Reduction of lipid levels(up to 30 months)
- Reduction of blood pressure(up to 30 months)
- Compliance rate of patients with healthy life style(up to 30 months)
- Cost-effectiveness rate of Endothelial Function Testing(up to 54 months)
- Compliance rate of patients with treatment target(up to 30 months)
- Compliance rate of patients with appropriate prescription by physicians(up to 30 months)
研究者
Wang Hongyu
Professor, Peking University Clinical Research Institute
Peking University