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Clinical Trials/NCT01020942
NCT01020942
Unknown
Not Applicable

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

Xijing Hospital1 site in 1 country500 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Injury
Sponsor
Xijing Hospital
Enrollment
500
Locations
1
Primary Endpoint
The primary outcome was assessing whether EA pretreatment before elective PCI reduced cTnI concentration at 48 hours.
Last Updated
14 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
June 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xijing Hospital
Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

The primary outcome was assessing whether EA pretreatment before elective PCI reduced cTnI concentration at 48 hours.

Time Frame: 48 hours after PCI

Secondary Outcomes

  • 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.)

Study Sites (1)

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