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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
1,000
To evaluate the effect of integration of non invasive endothelial function test (EFT) as a routine test in increasing appropriate treatment to reduce cardiovascular risk including prescription of lipid, blood pressure and glucose lowering medications by physicians at the clinic for patients with non-obstructive coronary artery disease (NOCAD) and the effect of introducing EFT as a routine test in reducing clinical endpoint (major adverse cardiovascular events) among patients with non-obstructive coronary artery disease(NOCAD).
Peking University Shougang Hospital
Beijing, China
RECRUITINGCompliance rate of patients to physicians prescription
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.
Time frame: up to 30 months
Total incidence number of Major Adverse Cardiovascular Events
The incidence number of MACE(Major Adverse Cardiovascular Events) including total death, non-fatal AMI or stroke(including stroke revascularization).
Time frame: up to 54 months
Mean improvement of endothelial function
The mean improvement in endothelial function from baseline to 12 months, estimated by RHI(Reactive Hyperemia Index).
Time frame: up to 30 months
Incidence number of Major Adverse Cardiovascular Events
The incidence number of MACE(Major Adverse Cardiovascular Events) during 0 to 12 months
Time frame: up to 30 months
Reduction of lipid levels
The reduction in lipid levels from baseline to 12 months
Time frame: up to 30 months
Reduction of blood pressure
The reduction in blood pressure from baseline to 12 months
Time frame: up to 30 months
Compliance rate of patients with treatment target
The percentage of patients with treatment target attained in terms of hypertension, diabetes, and dyslipidemia at 12 months after baseline.
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Time frame: up to 30 months
Compliance rate of patients with appropriate prescription by physicians
The percentage of patients with appropriate prescription of cholesterol, blood pressure and glucose lowering medications by physicians at 3, 6 and 12 months after baseline.
Time frame: up to 30 months
Compliance rate of patients with healthy life style
The percentage of patients with healthy life style at 3, 6 and 12 months after baseline. The healthy life style is defined as having no smoking, physical activities with at least 3 times a week and 30 min per time, BMI\<25 Kg/M2.
Time frame: up to 30 months
Cost-effectiveness rate of Endothelial Function Testing
The cost-effectiveness incremental ratio of Endothelial Function Testing in reducing MACE(Major Adverse Cardiovascular Events) .
Time frame: up to 54 months