Clinical trial NCT01020942: Cardioprotective Effects of Electroacupuncture Pretreatment Against Coronary Stenting
Official title: Cardioprotective of Electroacupuncture Pretreatment in Patients Underwent Coronary Stenting: A Prospective, Multicenter, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Injury
Keywords: ischemia
myocardial infarction
prognosis
pretreatment
electroacupuncture
stents
troponin
percutaneous coronary intervention
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2009-11-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: The primary outcome was assessing whether EA pretreatment before elective PCI reduced cTnI concentration at 48 hours.
timeFrame: 48 hours after PCI
Secondary outcomes:
measure: 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.
timeFrame: six months of PCI follow-up.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Lize Xiong, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.