Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease

Not Applicable

• Conditions: Non-obstructive Coronary Artery Disease
• Interventions: Other: Endothelial function guided therapy

• Registration Number: NCT04013204
• Lead Sponsor: Peking University

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.

Study Timeline

• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-07
• Study First Posted: 2019-07-09
• Study Start: 2019-08-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-11
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 1. Age: 18 years or older;
• 2. Patients with NOCAD defined by CT or CAG results of less than 50% occlusion;
• 3. Having signed their written informed consent.

Exclusion Criteria

• 1. Left ventricular ejection fraction ≤ 50%;
• 2. Serious endocrine diseases (severe hyperthyroidism, hypothyroidism);
• 3. Severe liver diseases (jaundice hepatitis, liver cirrhosis, liver failure);
• 4. Severe nephropathy (uremia, renal failure);
• 5. Severe inflammatory diseases (severe infection, lupus erythematosus, etc.);
• 6. Malignant tumor;
• 7. Mental disorders or cognitive disorders;
• 8. Participating in other interventional clinical trials;
• 9. There are any other factors that the treating doctors think are not suitable for inclusion or completion of this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Endothelial function guided therapy	Intervention group: Before the patient returns to the doctor and the prescription is issued, the EDCM system will feed back the EndoPAT test results to the responsible doctor through the automatically generated information on the doctor's mobile phone, but will not let the patient know the endothelium test results (blinded to the patient).

Primary Outcome Measures

Name	Time	Method
Total incidence number of Major Adverse Cardiovascular Events	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	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 Outcome Measures

Name	Time	Method
Mean improvement of endothelial function	up to 30 months	The mean improvement in endothelial function from baseline to 12 months, estimated by RHI(Reactive Hyperemia Index).
Incidence number of Major Adverse Cardiovascular Events	up to 30 months	The incidence number of MACE(Major Adverse Cardiovascular Events) during 0 to 12 months
Reduction of lipid levels	up to 30 months	The reduction in lipid levels from baseline to 12 months
Reduction of blood pressure	up to 30 months	The reduction in blood pressure from baseline to 12 months
Compliance rate of patients with healthy life style	up to 30 months	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.
Cost-effectiveness rate of Endothelial Function Testing	up to 54 months	The cost-effectiveness incremental ratio of Endothelial Function Testing in reducing MACE(Major Adverse Cardiovascular Events) .
Compliance rate of patients with treatment target	up to 30 months	The percentage of patients with treatment target attained in terms of hypertension, diabetes, and dyslipidemia at 12 months after baseline.
Compliance rate of patients with appropriate prescription by physicians	up to 30 months	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.

Trial Locations

Locations (1)

Peking University Shougang Hospital; 🇨🇳 Beijing, China