Cardioprotective Effects of Electroacupuncture Pretreatment Against Coronary Stenting

Myocardial Injury Clinical Trial

Official title:

Cardioprotective of Electroacupuncture Pretreatment in Patients Underwent Coronary Stenting: A Prospective, Multicenter, Randomized Control Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01020942
• Other study ID #: XJMZK016
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 24, 2009
• Last updated: December 15, 2011
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: November 2011
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myocardial Injury

Intervention

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.
• No intervention
The control patients were only placed needles at the bilateral Neiguan (PC 6)acupoints without electric stimulus.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was assessing whether EA pretreatment before elective PCI reduced cTnI concentration at 48 hours.		48 hours after PCI	No
Secondary	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.	No