NCT03418194

Brief Summary

The aim of this study was to observe the effect of transcutaneous acupoint electrical stimulation (TAES) on postoperative heart rate variability and high-sensitive cardiac troponin T of elderly patients with coronary heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable coronary-artery-disease

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

February 2, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

5 months

First QC Date

January 25, 2018

Last Update Submit

May 9, 2019

Conditions

Coronary Artery DiseaseAnesthesia

Keywords

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

  • High-sensitive cardiac troponin T

    Cardiac troponin T are components of the contractile apparatus of myocardial cells and are expressed almost exclusively in the heart. High-sensitive cardiac troponin T is cardiac troponin T mesured by high-sensitive method.

    1 week

Secondary Outcomes (3)

  • heart rate variability

    1 week

  • CK

    1 week

  • CRP

    1 week

Study Arms (2)

TAES group

EXPERIMENTAL

Patients in group TAES group received transcutaneous acupoint electrical stimulation (disperse-dense waves, frequency 4/20Hz) at the points of PC6 (Neiguan) and PC4 (Ximen) from 30 min before anesthesia induction to the end of surgery,

Procedure: transcutaneous acupoint electrical stimulation

control group

PLACEBO COMPARATOR

Patients in group C received electrode plate atthe points of PC6 (Neiguan) and PC4 (Ximen) without any electrical stimulation.

Procedure: sham transcutaneous acupoint electrical stimulation

Interventions

transcutaneous acupoint electrical stimulationPROCEDURE

Transcutaneous acupoint electrical stimulation(TAES) is a kind of noninvasive therapy similar to acupuncture and moxibustion. Its physiological effect is similar to that of electroacupuncture and hand acupuncture which is a Chinese traditonal therapy using acupuncture.

TAES group
sham transcutaneous acupoint electrical stimulationPROCEDURE

Sham transcutaneous acupoint electrical stimulation is the same procedure as transcutaneous acupoint electrical stimulation at points without electronic stimulation.

control group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Stable angina pectoris
  • Slilent myocardial ischemia
  • Remote myocardial infarction

You may not qualify if:

  • Congenital heart disease
  • Have a history of cardiac surgery
  • Frequent ventricular / atrial premature beats, atrial fibrillation and other serious arrhythmia
  • Heart conduction diseases
  • Antiarrhythmic drugs used
  • Temporary and permanent pacemaker used
  • Intraoperative blood loss\>800ml

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Hospital of Hebei Medical Universit

Shijiazhuang, Hebei, 050051, China

Location

Related Publications (2)

  • Mazzeo AT, La Monaca E, Di Leo R, Vita G, Santamaria LB. Heart rate variability: a diagnostic and prognostic tool in anesthesia and intensive care. Acta Anaesthesiol Scand. 2011 Aug;55(7):797-811. doi: 10.1111/j.1399-6576.2011.02466.x. Epub 2011 Jun 9.

    PMID: 21658013RESULT

  • Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.

    PMID: 28444280RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Xiuli Wang, MD, PhD

    Third Hospital of Hebei Medical Universit Department of Anesthesiology

    STUDY CHAIR

  • Huizhou li, M.D

    Third Hospital of Hebei Medical Universit Department of Anesthesiology

    STUDY DIRECTOR

  • Chuan Wu, M.D

    Third Hospital of Hebei Medical Universit Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 1, 2018

Study Start

February 2, 2018

Primary Completion

June 21, 2018

Study Completion

June 30, 2018

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations

CN(1)