Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Fastigial Nucleus Stimulation for Coronary Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04121715
Recruitment Status : Enrolling by invitation
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
the Third Hospital of Mianyang
Information provided by (Responsible Party):
Affiliated Hospital of North Sichuan Medical College

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

Condition or disease Intervention/treatment Phase
Coronary Disease Device: Fastigial Nucleus Stimulation Drug: Standard treatment Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized Controlled Trial of Fastigial Nucleus Stimulation in Patients With Coronary Heart Disease
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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"
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 Name: Standard treatment

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121715


Locations
Layout table for location information
China, Sichuan
The Third Hospital of Mianyang
Mianyang, Sichuan, China, 0816
Sponsors and Collaborators
Affiliated Hospital of North Sichuan Medical College
the Third Hospital of Mianyang
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Affiliated Hospital of North Sichuan Medical College
ClinicalTrials.gov Identifier: NCT04121715    
Other Study ID Numbers: ScHFPC-16PJ176
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6months of study completion
Access Criteria: Data access requests will be reviewed by an external independent Reviwe Panel.Requestors will be required to sign a Data Access Agreement
URL: http://bethesda.org

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Affiliated Hospital of North Sichuan Medical College:
coronary heart disease
fastigial nucleus stimulation
inflammatory factors
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases