Cardioprotective Effects of Electroacupuncture Pretreatment Against Coronary Stenting

Study Overview
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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.

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

Conditions
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Myocardial Injury

Intervention / Treatment
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* Procedure: Electroacupuncture stimulation
* Procedure: No intervention


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pretreatment<br> | Procedure: Electroacupuncture stimulation<br>* 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．<br>* Other names: Preconditioning;|
| No Intervention: Control<br> | Procedure: No intervention<br>* The control patients were only placed needles at the bilateral Neiguan (PC 6)acupoints without electric stimulus.<br>* Other names: Sham pretreatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was assessing whether EA pretreatment before elective PCI reduced cTnI concentration at 48 hours. |  | 48 hours after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemia, myocardial infarction, prognosis, pretreatment, electroacupuncture, stents, troponin, percutaneous coronary intervention