Cardioprotective Effects of Electroacupuncture Pretreatment Against Coronary Stenting
|ClinicalTrials.gov Identifier: NCT01020942|
Recruitment Status : Unknown
Verified November 2011 by Xijing Hospital.
Recruitment status was: Enrolling by invitation
First Posted : November 26, 2009
Last Update Posted : December 16, 2011
|Condition or disease||Intervention/treatment|
|Myocardial Injury||Procedure: Electroacupuncture stimulation Procedure: No intervention|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Cardioprotective of Electroacupuncture Pretreatment in Patients Underwent Coronary Stenting: A Prospective, Multicenter, Randomized Control Trial|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||June 2012|
Procedure: 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．
Other Name: Preconditioning
|No Intervention: Control||
Procedure: No intervention
The control patients were only placed needles at the bilateral Neiguan (PC 6)acupoints without electric stimulus.
Other Name: Sham pretreatment
- 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 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. [ Time Frame: six months of PCI follow-up. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020942
|Xi'an, Shaanxi, China, 710032|
|Study Director:||Lize Xiong, M.D., Ph.D.||Xijing Hospital|