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NCT01175681 Clinical Trial

Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery

Heart Valve Diseases Clinical Trial

Official title:
Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01175681
Other study ID # ischemia
Secondary ID
Status Completed
Phase N/A
First received August 3, 2010
Last updated July 20, 2011
Start date December 2007
Est. completion date June 2011

Study information
Verified date July 2010
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date June 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All heart valve diseases needing heart valve surgery.

Exclusion Criteria:

- All four limbs existed ischemic condition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
China Guangzhou First Municipal People's Hospital Guangzhou Guangdong

Sponsors (2)
Lead Sponsor Collaborator
Sun Yat-sen University Guangzhou First Municipal People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary plasma troponin I level The investigators will measure the plasma troponin I level in several time points before and after surgery in each patient. with 7 days after surgery No
Secondary serum creatinine within 7 days after surgery No
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