Fastigial Nucleus Stimulation for Coronary Heart Disease

Coronary Disease Clinical Trial

Official title:

A Prospective, Multicenter, Randomized Controlled Trial of Fastigial Nucleus Stimulation in Patients With Coronary Heart Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04121715
• Other study ID #: ScHFPC-16PJ176
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: January 2022

Study information

• Verified date: October 2019
• Source: Af?liated Hospital of North Sichuan Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: January 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Device:
• 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

Drug:
• 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

Locations

Country	Name	City	State
China	The Third Hospital of Mianyang	Mianyang	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Af?liated Hospital of North Sichuan Medical College	the Third Hospital of Mianyang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observe the changes of serum IL-6 after treatment.	Observe the changes of serum IL-6 levels(pg/ml)after treatment in the two groups of patients.	baseline,1month
Primary	Observe the changes of serum hs-CRP after treatment.	Observe the changes of serum hs-CRP levels(mg/l)after treatment in the two groups of patients.	baseline,1month
Primary	Observe the changes of serum TNF-a after treatment.	Observe the changes of serum TNF-a levels(pg/ml)after treatment in the two groups of patients.	baseline,1month
Primary	Observe the changes of serum Lp-PLA2 after treatment.	Observe the changes of serum Lp-PLA2 levels(ng/ml)after treatment in the two groups of patients.	baseline,1month
Primary	Observe the changes of serum SOD(Superoxide dismutase) after treatment.	Observe the changes of serum SOD levels(ng/ml)after treatment in the two groups of patients.	baseline,1month
Primary	Observe the changes of serum GPX(Glutathione peroxidase) after treatment.	Observe the changes of serum GPX levels(ng/ml)after treatment in the two groups of patients.	baseline,1month
Primary	Observe the changes of serum MDA(Malondialdehyde) after treatment.	Observe the changes of serum MDA levels(nmol/ml)after treatment in the two groups of patients.	baseline,1month
Primary	Observe the changes of serum AOPP(Advanced oxidation protein product) after treatment.	Observe the changes of serum AOPP levels(umol/l)after treatment in the two groups of patients.	baseline,1month
Primary	Observe the changes of SDNN(Standard Deviation of the NN intervals) after treatment.	Observe the changes of SDNN(ms)after treatment in the two groups of patients.	baseline,1month
Primary	Observe the changes of SDANN(Standard Deviation of mean NN intervals in 5-minute recordings) after treatment.	Observe the changes of SDANN(ms)after treatment in the two groups of patients.	baseline,1month
Primary	Observe the changes of SDNN In(Average of the standard deviation of the NN interval every 5 minutes) after treatment.	Observe the changes of SDNN In(ms)after treatment in the two groups of patients.	baseline,1month
Primary	Observe the changes of rMSSD(square root of the mean squared differences of successive NN intervals) after treatment.	Observe the changes of rMSSD(ms)after treatment in the two groups of patients.	baseline,1month
Primary	Observe the changes of pNN50(Percentage of the difference between adjacent RR intervals >50ms ) after treatment.	Observe the changes of pNN50(%)after treatment in the two groups of patients.	baseline,1month
Secondary	Follow-up rate of major cardiovascular events	The improvement of symptoms and the in-stent restenosis, myocardial infarction, readmission due to heart failure, and mortality were observed in the two groups after 12 months of discharge.	12months