Cardioprotective Effects of Electroacupuncture Pretreatment Against Coronary Stenting

NCT ID: NCT01020942

Last Updated: 2011-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myocardial Injury

Keywords

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ischemia myocardial infarction prognosis pretreatment electroacupuncture stents troponin percutaneous coronary intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Pretreatment

Group Type EXPERIMENTAL

Electroacupuncture stimulation

Intervention Type PROCEDURE

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.

Control

Group Type NO_INTERVENTION

No intervention

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

No intervention

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

Intervention Type PROCEDURE

Other Intervention Names

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Preconditioning Sham pretreatment

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lize Xiong, M.D., Ph.D.

Role: STUDY_DIRECTOR

Xijing Hospital

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 26011261 (View on PubMed)

Other Identifiers

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XJMZK016

Identifier Type: -

Identifier Source: org_study_id