Back to resultsEffect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery
Primary Purpose
Heart Valve Diseases
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remote ischaemic preconditioning
Sponsored by
About this trial
This is an interventional prevention trial for Heart Valve Diseases focused on measuring rheumatic heart disease, degenerated heart valve disease, heart valve prolapse
Eligibility Criteria
Inclusion Criteria:
- All heart valve diseases needing heart valve surgery.
Exclusion Criteria:
- All four limbs existed ischemic condition
Sites / Locations
- Guangzhou First Municipal People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
treatment
untreated
Arm Description
remote ischaemic preconditioning
control
Outcomes
Primary Outcome Measures
plasma troponin I level
The investigators will measure the plasma troponin I level in several time points before and after surgery in each patient.
Secondary Outcome Measures
serum creatinine
Full Information
NCT ID
NCT01175681
First Posted
August 3, 2010
Last Updated
July 20, 2011
Sponsor
Sun Yat-sen University
Collaborators
Guangzhou First People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01175681
Brief Title
Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery
Official Title
Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sun Yat-sen University
Collaborators
Guangzhou First People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases
Keywords
rheumatic heart disease, degenerated heart valve disease, heart valve prolapse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
remote ischaemic preconditioning
Arm Title
untreated
Arm Type
No Intervention
Arm Description
control
Intervention Type
Procedure
Intervention Name(s)
remote ischaemic preconditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
plasma troponin I level
Description
The investigators will measure the plasma troponin I level in several time points before and after surgery in each patient.
Time Frame
with 7 days after surgery
Secondary Outcome Measure Information:
Title
serum creatinine
Time Frame
within 7 days after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All heart valve diseases needing heart valve surgery.
Exclusion Criteria:
All four limbs existed ischemic condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-song Ou, MD,PhD
Organizational Affiliation
The Frist Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou First Municipal People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
17707752
Citation
Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
Results Reference
background
PubMed Identifier
22107759
Citation
Xie JJ, Liao XL, Chen WG, Huang DD, Chang FJ, Chen W, Luo ZL, Wang ZP, Ou JS. Remote ischaemic preconditioning reduces myocardial injury in patients undergoing heart valve surgery: randomised controlled trial. Heart. 2012 Mar;98(5):384-8. doi: 10.1136/heartjnl-2011-300860. Epub 2011 Nov 22.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov
Description
Pubmed
Learn more about this trial
Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery
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