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| Name | Class |
|---|---|
| the Third Hospital of Mianyang | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard medication | Active Comparator | standard medication:Refer to the "Guidelines for Rational Use of Coronary Heart Diseases" |
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| standard medication+fastigial nucleus stimulation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fastigial Nucleus Stimulation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Observe the changes of serum TNF-α after treatment. | Observe the changes of serum TNF-α levels（pg/ml）after treatment in the two groups of patients. | baseline,1month |
| 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 |
| 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 |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Runfeng Zhang, Ph.D | the Third Hospital of Mianyang | Study Chair |
| Wensong Li, master | the Third Hospital of Mianyang | Principal Investigator |
| Xin Lei, master | Affiliated Hospital of North Sichuan Medical College | Principal Investigator |
| Xiaoju Liu, master | Affiliated Hospital of North Sichuan Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Hospital of Mianyang | Mianyang | Sichuan | 0816 | China |
De-identified individual participant data for all primary and secondary outcome measures will be made available
Data will be available within 6months of study completion
Data access requests will be reviewed by an external independent Reviwe Panel.Requestors will be required to sign a Data Access Agreement
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Standard treatment | 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 |
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| baseline,1month |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |