Clinical trial NCT04121715: Fastigial Nucleus Stimulation for Coronary Heart Disease
Official title: A Prospective, Multicenter, Randomized Controlled Trial of Fastigial Nucleus Stimulation in Patients With Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Disease
Keywords: coronary heart disease
fastigial nucleus stimulation
inflammatory factors
Lead sponsor: Afﬁliated Hospital of North Sichuan Medical College
Sponsor class: OTHER
Collaborators: name: the Third Hospital of Mianyang
First posted: 2019-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Observe the changes of serum IL-6 after treatment.
timeFrame: baseline,1month
measure: Observe the changes of serum hs-CRP after treatment.
timeFrame: baseline,1month
measure: Observe the changes of serum TNF-α after treatment.
timeFrame: baseline,1month
measure: Observe the changes of serum Lp-PLA2 after treatment.
timeFrame: baseline,1month
measure: Observe the changes of serum SOD（Superoxide dismutase） after treatment.
timeFrame: baseline,1month
measure: Observe the changes of serum GPX（Glutathione peroxidase） after treatment.
timeFrame: baseline,1month
measure: Observe the changes of serum MDA（Malondialdehyde） after treatment.
timeFrame: baseline,1month
measure: Observe the changes of serum AOPP（Advanced oxidation protein product） after treatment.
timeFrame: baseline,1month
measure: Observe the changes of SDNN（Standard Deviation of the NN intervals） after treatment.
timeFrame: baseline,1month
measure: Observe the changes of SDANN（Standard Deviation of mean NN intervals in 5-minute recordings） after treatment.
timeFrame: baseline,1month
measure: Observe the changes of SDNN In（Average of the standard deviation of the NN interval every 5 minutes） after treatment.
timeFrame: baseline,1month
measure: Observe the changes of rMSSD（square root of the mean squared differences of successive NN intervals） after treatment.
timeFrame: baseline,1month
measure: Observe the changes of pNN50（Percentage of the difference between adjacent RR intervals >50ms ） after treatment.
timeFrame: baseline,1month
Secondary outcomes:
measure: Follow-up rate of major cardiovascular events
timeFrame: 12months
Other outcomes:
Locations:
city: Mianyang
country: China
facility: The Third Hospital of Mianyang
state: Sichuan
Study officials:
affiliation: the Third Hospital of Mianyang
name: Runfeng Zhang, Ph.D
role: STUDY_CHAIR
affiliation: the Third Hospital of Mianyang
name: Wensong Li, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Afﬁliated Hospital of North Sichuan Medical College
name: Xin Lei, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Afﬁliated Hospital of North Sichuan Medical College
name: Xiaoju Liu, master
role: PRINCIPAL_INVESTIGATOR
References: