Fastigial Nucleus Stimulation for Coronary Heart Disease

NCT04121715 | Unknown

• 1 other identifier: ScHFPC-16PJ176
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Disease

Keywords

coronary heart disease; fastigial nucleus stimulation; inflammatory factors

Outcome Measures

Primary Outcomes (13)

• 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.

  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

Secondary Outcomes (1)

• Follow-up rate of major cardiovascular events

  12months

Study Arms (2)

standard medication

ACTIVE COMPARATOR

standard medication:Refer to the "Guidelines for Rational Use of Coronary Heart Diseases"

Drug: Standard treatment

standard medication+fastigial nucleus stimulation

EXPERIMENTAL

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; Drug: Standard treatment

Interventions

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

Also known as: Standard treatment

standard medication+fastigial nucleus stimulation

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

standard medication; standard medication+fastigial nucleus stimulation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of North Sichuan Medical College: lead
• the Third Hospital of Mianyang: collaborator

Study Sites (1)

The Third Hospital of Mianyang

Mianyang, Sichuan, 0816, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 10, 2019
• Study Start: January 16, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

CN (1)