NCT01020266

Brief Summary

The purpose of this study is to evaluate the neuroprotective effect of electroacupuncture pretreatment in patients undergoing cardiac surgery as an preventive sequela in a randomized and controlled clinical trial. In addition, to investigate the role of inflammatory responses in the precess of the protection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 25, 2015

Status Verified

November 1, 2009

Enrollment Period

9 months

First QC Date

November 22, 2009

Last Update Submit

June 23, 2015

Conditions

StrokeBrain Injuries

Keywords

brain protectioncardiac surgeryheart valve replacementelectroacupuncturepretreatmentpreconditioningThoracic Surgery

Outcome Measures

Primary Outcomes (1)

  • Cerebrovascular complications and Score of neurological defect

    before treatment, after the first treatment, 7, 28days after treatment and follow up at 6 months after treatment

Secondary Outcomes (1)

  • The S-100B and NSE blood level

    before treatment, after the last treatment, before surgery, and the first 72 hours of surgery follow-up

Study Arms (2)

Electroacupuncture

ACTIVE COMPARATOR
Procedure: Electroacupuncture pretreatment

Control

SHAM COMPARATOR
Procedure: non electroacupuncture stimulation

Interventions

non electroacupuncture stimulationPROCEDURE

The same procedure as electroacupuncture except stimulation

Control
Electroacupuncture pretreatmentPROCEDURE

According to the theory of traditional Chinese medicine, Baihui(GV20) acupoint was chosen and the acupuncture points were identified according to traditional anatomical localization. Once insertion was made at the acupuncture point, the needle was stimulated electrically with the intensity of 0.8-1.9 mA and frequency of 5/30 Hz for 30 min per day using an Electronic Acupuncture Treatment Instrument for 5 consecutive days before the heart valve replacement surgery．

Also known as: Acupuncture, preconditioning, electric stimulation
Electroacupuncture

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who have the indication for aortic or mitral valve replacement
  • patients would like to accept the follow-up and sign the informed consent
  • patients with heart function of NYHA I-III degree.

You may not qualify if:

  • pregnant or nursing women
  • comorbid with coronary artery disease
  • patients with heart function of NYHA IV degree
  • renal dysfunction with serum creatinine level\>or=2mg/dl(177umol/L)
  • anticipated life span \< 12 months
  • enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

StrokeBrain Injuries

Interventions

Acupuncture TherapyElectric Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical StimulationInvestigative Techniques

Study Officials

  • Aideng Weng, Ph.D.

    Xijing Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2009

First Posted

November 25, 2009

Study Start

December 1, 2009

Primary Completion

September 1, 2010

Study Completion

June 1, 2013

Last Updated

June 25, 2015

Record last verified: 2009-11

Locations

CN(1)