Cardioprotective Effects of Electroacupuncture Pretreatment Against Coronary Stenting

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Myocardial Injury

Treatments: Procedure: No intervention; Procedure: Electroacupuncture stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01020942

XJMZK016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Pretreatment

Experimental group

Treatment:

Procedure: Electroacupuncture stimulation

Control

No Intervention group

Treatment:

Procedure: No intervention