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Cardioprotective Effects of Electroacupuncture Pretreatment Against Coronary Stenting

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ClinicalTrials.gov Identifier: NCT01020942
Recruitment Status : Unknown
Verified November 2011 by Xijing Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : November 26, 2009
Last Update Posted : December 16, 2011
Information provided by (Responsible Party):
Xijing Hospital

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.

Condition or disease Intervention/treatment
Myocardial Injury Procedure: Electroacupuncture stimulation Procedure: No intervention

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cardioprotective of Electroacupuncture Pretreatment in Patients Underwent Coronary Stenting: A Prospective, Multicenter, Randomized Control Trial
Study Start Date : January 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : June 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The primary outcome was assessing whether EA pretreatment before elective PCI reduced cTnI concentration at 48 hours. [ Time Frame: 48 hours after PCI ]

Secondary Outcome Measures :
  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. [ Time Frame: six months of PCI follow-up. ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020942

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01020942     History of Changes
Other Study ID Numbers: XJMZK016
First Posted: November 26, 2009    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: November 2011

Keywords provided by Xijing Hospital:
myocardial infarction
percutaneous coronary intervention