Fastigial Nucleus Stimulation for Coronary Heart Disease

October 8, 2019 updated by: Affiliated Hospital of North Sichuan Medical College

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Mianyang, Sichuan, China, 0816
        • The Third Hospital of Mianyang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: standard medication
standard medication:Refer to the "Guidelines for Rational Use of Coronary Heart Diseases"
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
EXPERIMENTAL: 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"
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
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
Other Names:
  • Standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observe the changes of serum IL-6 after treatment.
Time Frame: baseline,1month
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.
Time Frame: baseline,1month
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.
Time Frame: baseline,1month
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.
Time Frame: baseline,1month
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.
Time Frame: baseline,1month
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.
Time Frame: baseline,1month
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.
Time Frame: baseline,1month
Observe the changes of serum MDA levels（nmol/ml）after treatment in the two groups of patients.
baseline,1month
Observe the changes of serum AOPP（Advanced oxidation protein product） after treatment.
Time Frame: baseline,1month
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.
Time Frame: baseline,1month
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.
Time Frame: baseline,1month
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.
Time Frame: baseline,1month
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.
Time Frame: baseline,1month
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.
Time Frame: baseline,1month
Observe the changes of pNN50（%）after treatment in the two groups of patients.
baseline,1month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up rate of major cardiovascular events
Time Frame: 12months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of North Sichuan Medical College

Collaborators

the Third Hospital of Mianyang

Investigators

  • Study Chair: Runfeng Zhang, Ph.D, The Third Hospital of Mianyang
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 16, 2019

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (ACTUAL)

October 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ScHFPC-16PJ176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available

IPD Sharing Time Frame

Data will be available within 6months of study completion

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent Reviwe Panel.Requestors will be required to sign a Data Access Agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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