Fastigial Nucleus Stimulation for Coronary Heart Disease

NCT ID: NCT04121715

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-16
• Study Completion Date: 2022-01-31

Brief Summary

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

Detailed 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.

Conditions

Coronary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard medication

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

Group Type: ACTIVE_COMPARATOR

Standard treatment

Intervention Type: DRUG

Refer to the "Guidelines for Rational Use of Coronary Heart Diseases".rational selection of antiplatelet drugs, statins, etc. according to the patient's condition

standard medication+fastigial nucleus stimulation

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"

Group Type: EXPERIMENTAL

Fastigial Nucleus Stimulation

Intervention Type: DEVICE

Select mode 3, frequency 136, intensity below 90, ratio 1.0-2.0, based on the patient's no discomfort. The main pole is attached to the bilateral mastoid, and the auxiliary pole is attached to the bilateral internal cave. Non-invasive introduction of bio-electricity into the cerebellar nucleus for stimulation

Standard treatment

Intervention Type: DRUG

Refer to the "Guidelines for Rational Use of Coronary Heart Diseases".rational selection of antiplatelet drugs, statins, etc. according to the patient's condition

Interventions

Fastigial Nucleus Stimulation

Select mode 3, frequency 136, intensity below 90, ratio 1.0-2.0, based on the patient's no discomfort. The main pole is attached to the bilateral mastoid, and the auxiliary pole is attached to the bilateral internal cave. Non-invasive introduction of bio-electricity into the cerebellar nucleus for stimulation

Intervention Type: DEVICE

Standard treatment

Refer to the "Guidelines for Rational Use of Coronary Heart Diseases".rational selection of antiplatelet drugs, statins, etc. according to the patient's condition

Intervention Type: DRUG

Other Intervention Names

Standard treatment

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

the Third Hospital of Mianyang

UNKNOWN

Sponsor Role: collaborator

Affiliated Hospital of North Sichuan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Runfeng Zhang, Ph.D

Role: STUDY_CHAIR

the Third Hospital of Mianyang

Wensong Li, master

Role: PRINCIPAL_INVESTIGATOR

the Third Hospital of Mianyang

Xin Lei, master

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of North Sichuan Medical College

Xiaoju Liu, master

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of North Sichuan Medical College

Locations

The Third Hospital of Mianyang

Mianyang, Sichuan, China

Countries

China

Other Identifiers

ScHFPC-16PJ176

Identifier Type: -

Identifier Source: org_study_id