Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease (EndoFIND Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-obstructive Coronary Artery Disease
- Sponsor
- Peking University
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Total incidence number of Major Adverse Cardiovascular Events
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Wang Hongyu
Professor, Peking University Clinical Research Institute
Peking University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Total incidence number of Major Adverse Cardiovascular Events
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)