Fastigial Nucleus Stimulation for Coronary Heart Disease

Affiliated Hospital of North Sichuan Medical College

Status: Unknown

Conditions: Coronary Disease

Treatments: Drug: Standard treatment; Device: Fastigial Nucleus Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04121715

ScHFPC-16PJ176

Details and patient eligibility

About

To observe the effects of fastigial nucleus stimulation on serum inflammation, oxidative stress related factors, cardiac autonomic function and prognosis in patients with coronary heart disease

Full description

In recent years, with the improvement of the material living standards of the investigators residents and the change of working lifestyle, the prevalence and mortality of coronary heart disease (CHD) in urban and rural residents in China have increased year by year. According to statistics, the number of patients with coronary heart disease in China is currently 11 million. Coronary heart disease has become a major health problem in China. At present, it is found that inflammatory reaction and oxidative stress factors are involved in the occurrence and development of coronary heart disease, and their indicators such as heart rate variability are related to the prognosis of coronary heart disease. Fastigial nucleus stimulation (FNS) has been widely used in the treatment of various diseases such as cerebrovascular disease, migraine, and eye diseases. The study found that FNS can reduce inflammatory cytokines and oxidative stress factors in ischemic myocardium and improve heart rate variability in rats with myocardial infarction. The aim of this study was to investigate whether FNS can improve the aforementioned indicators and clinical outcomes in patients with coronary heart disease.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Coronary angiography was performed after admission, and coronary heart disease was diagnosed (coronary angiography showed at least one coronary artery with a diameter reduction of ≥50% from more than two different angles)
• Patients and their families agreed and signed informed consent

Exclusion criteria

• Severe chronic heart failure, and LVEF <30%
• Body temperature > 38 ° C and / or combined with severe infection in any system
• Severe liver and kidney dysfunction
• Malignant tumor
• Autoimmune diseases
• High blood pressure and diabetes with severe comorbidities
• Use of implantable electronic devices
• Intracranial implanted vascular stents
• Surface treatment electrode conductive materials Allergic or mastoid skin lesions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

standard medication

Active Comparator group

Description:

standard medication:Refer to the "Guidelines for Rational Use of Coronary Heart Diseases"

Treatment:

Drug: Standard treatment

standard medication+fastigial nucleus stimulation

Experimental group

Description:

1. fastigial nucleus stimulation:Use fastigial nucleus stimulation therapy device (Shanghai Renhe Medical Equipment Co., Ltd. CVFT series), each stimulation for 30 min, once a day, each patient treatment for about 20 days. 2. standard medication:Refer to the "Guidelines for Rational Use of Coronary Heart Diseases"

Treatment:

Device: Fastigial Nucleus Stimulation

Drug: Standard treatment