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

Peking University

Status: Enrolling

Conditions: Non-obstructive Coronary Artery Disease

Treatments: Other: Endothelial function guided therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04013204

PUCRI-2019- EndoFIND-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups

Intervention group

Experimental group

Description:

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).

Treatment:

Other: Endothelial function guided therapy

Control group

No Intervention group

Description:

Control group: The EDCM system will not report the EndoPAT test results to the responsible doctor (the doctor cannot see the final EFT results), nor can the patients know the EFT results.