Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery
This study has been completed.
Sponsor:
Sun Yat-sen University
Collaborator:
Guangzhou First Municipal People’s Hospital
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01175681
First received: August 3, 2010
Last updated: July 20, 2011
Last verified: July 2010
| Tracking Information | |||||
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| First Received Date ICMJE | August 3, 2010 | ||||
| Last Updated Date | July 20, 2011 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01175681 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
serum creatinine [ Time Frame: within 7 days after surgery ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery | ||||
| Official Title ICMJE | Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Heart Valve Diseases | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 73 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01175681 | ||||
| Other Study ID Numbers ICMJE | ischemia | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jing-song Ou/ professor, The First Affiliated Hospital, Sun Yat-sen University. | ||||
| Study Sponsor ICMJE | Sun Yat-sen University | ||||
| Collaborators ICMJE | Guangzhou First Municipal People’s Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Sun Yat-sen University | ||||
| Verification Date | July 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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