Cardioprotective Effects of Electroacupuncture Pretreatment Against Coronary Stenting

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01020942
First received: November 24, 2009
Last updated: December 15, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Myocardial Injury
Procedure: Electroacupuncture stimulation
Procedure: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cardioprotective of Electroacupuncture Pretreatment in Patients Underwent Coronary Stenting: A Prospective, Multicenter, Randomized Control Trial

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • The primary outcome was assessing whether EA pretreatment before elective PCI reduced cTnI concentration at 48 hours. [ Time Frame: 48 hours after PCI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: six months of PCI follow-up. ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pretreatment Procedure: Electroacupuncture stimulation
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.
Other Name: Preconditioning
No Intervention: Control Procedure: No intervention
The control patients were only placed needles at the bilateral Neiguan (PC 6)acupoints without electric stimulus.
Other Name: Sham pretreatment

Detailed Description:

Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases.Troponin release is a sensitive and specific marker of myocyte necrosis and infarction resulting from a form of ischemia/reperfusion injury, downstream embolization of atheromatous material, and coronary side-branch occlusion. A number of studies have demonstrated that procedure-related troponin release is associated with subsequent cardiovascular events.

Transient sublethal episodes of ischemia before a prolonged ischemia/reperfusion injury, known as ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI).Electroacupuncture (EA) stimulus, as a pretreatment method, limits MI size in animal models. However, there are limited outcome to demonstrate protection from EA pretreatment during PCI. The present study investigated the ability of EA pretreatment to attenuate cardiac troponin I (cTnI) release after elective PCI in a single-center, randomized controlled trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020942

Locations
China, Shaanxi
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Director: Lize Xiong, M.D., Ph.D. Xijing Hospital
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01020942     History of Changes
Other Study ID Numbers: XJMZK016
Study First Received: November 24, 2009
Last Updated: December 15, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
ischemia
myocardial infarction
prognosis
pretreatment
electroacupuncture
stents
troponin
percutaneous coronary intervention

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2014