Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery
Remote ischaemic preconditioning has shown its cardiac protective effect during heart surgery including coronary artery bypass graft surgery, congenital heart disease and aneurysm. However, no data was reported on heart valve disease surgery. Rheumatic heart disease is one of the major heart diseases requiring surgery in China. Thus, the investigators chose heart valve disease as a focus to see whether remote ischaemic preconditioning also has cardiac protective effect during heart valve surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery|
- plasma troponin I level [ Time Frame: with 7 days after surgery ] [ Designated as safety issue: No ]The investigators will measure the plasma troponin I level in several time points before and after surgery in each patient.
- serum creatinine [ Time Frame: within 7 days after surgery ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Study Completion Date:||June 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
remote ischaemic preconditioning
Procedure: remote ischaemic preconditioning
Remote ischaemic preconditioning consisted of three 5-min cycles of right upper arm ischaemia, which was induced by an automated cuff -inflator placed on the right upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated. There was a 5- to 10-min interval between completion of the remote ischaemic preconditioning protocol and initiation of bypass.Control patients had a deflated cuff placed on the right upper arm for 30 min.
No Intervention: untreated
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175681
|Guangzhou First Municipal People's Hospital|
|Guangzhou, Guangdong, China, 510180|
|Principal Investigator:||Jing-song Ou, MD,PhD||The Frist Affiliated Hospital, Sun Yat-sen University|