NCT01020942

Brief Summary

Myocyte necrosis as a result of elective percutaneous coronary intervention (PCI) occurs in approximately one third of cases and is associated with subsequent cardiovascular events. This study assesses the ability of electroacupuncture (EA) pretreatment to attenuate cardiac troponin I (cTnI) release after elective PCI.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 16, 2011

Status Verified

November 1, 2011

Enrollment Period

1.9 years

First QC Date

November 24, 2009

Last Update Submit

December 15, 2011

Conditions

Myocardial Injury

Keywords

ischemiamyocardial infarctionprognosispretreatmentelectroacupuncturestentstroponinpercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was assessing whether EA pretreatment before elective PCI reduced cTnI concentration at 48 hours.

    48 hours after PCI

Secondary Outcomes (1)

  • Secondary outcomes were the effect of EA pretreatment on ischemic symptoms, ECG evidence of ischemia during coronary balloon occlusion, CRP,and major adverse cardiac events (MACE) at 6 months.

    six months of PCI follow-up.

Study Arms (2)

Pretreatment

EXPERIMENTAL
Procedure: Electroacupuncture stimulation

Control

NO INTERVENTION
Procedure: No intervention

Interventions

Electroacupuncture stimulationPROCEDURE

According to the theory of traditional Chinese medicine, bilateral Neiguan (PC 6) acupoints were chosen and identified according to traditional anatomical localizations. Once insertion of original needles was made at the acupoints, the needle was stimulated electrically with the intensity of 2-6 mA and frequency of 2/30 Hz using the Electronic Acupuncture Treatment Instrument until the patient felt the so-called 'Teh Chi' sensation of heaviness, numbness and swelling. The pretreatment was individualized based on patients sex, age, weight and felt and given 1 time per day for 5 consecutive days before the heart valve replacement surgery．

Also known as: Preconditioning
Pretreatment
No interventionPROCEDURE

The control patients were only placed needles at the bilateral Neiguan (PC 6)acupoints without electric stimulus.

Also known as: Sham pretreatment
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients \> 18 of age who are undergoing elective PCI and are able to give informed consent are eligible for study.

You may not qualify if:

  • Emergency PCI,
  • Elevation of cTnI before PCI taken at the preadmission clinic,
  • Women of child-bearing age,
  • Nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning blocking medication, respectively), and
  • Severe comorbidity (estimated life expectancy \< 6 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • Wang Q, Liang D, Wang F, Li W, Han Y, Zhang W, Xie Y, Xin W, Zhou B, Sun D, Cao F, Xiong L. Efficacy of electroacupuncture pretreatment for myocardial injury in patients undergoing percutaneous coronary intervention: A randomized clinical trial with a 2-year follow-up. Int J Cardiol. 2015 Sep 1;194:28-35. doi: 10.1016/j.ijcard.2015.05.043. Epub 2015 May 13.

    PMID: 26011261DERIVED

MeSH Terms

Conditions

IschemiaMyocardial Infarction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionNecrosis

Study Officials

  • Lize Xiong, M.D., Ph.D.

    Xijing Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 26, 2009

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

December 16, 2011

Record last verified: 2011-11

Locations

CN(1)