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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01175681
First Posted: August 5, 2010
Last Update Posted: July 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Guangzhou First People's Hospital
Information provided by:
Sun Yat-sen University
  Purpose
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.

Condition Intervention
Heart Valve Diseases Procedure: remote ischaemic preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • plasma troponin I level [ Time Frame: with 7 days after surgery ]
    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 [ Time Frame: within 7 days after surgery ]

Enrollment: 73
Study Start Date: December 2007
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
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
control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All heart valve diseases needing heart valve surgery.

Exclusion Criteria:

  • All four limbs existed ischemic condition
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175681


Locations
China, Guangdong
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, China, 510180
Sponsors and Collaborators
Sun Yat-sen University
Guangzhou First People's Hospital
Investigators
Principal Investigator: Jing-song Ou, MD,PhD The Frist Affiliated Hospital, Sun Yat-sen University
  More Information

Additional Information:
Pubmed  This link exits the ClinicalTrials.gov site

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jing-song Ou/ professor, The First Affiliated Hospital, Sun Yat-sen University.
ClinicalTrials.gov Identifier: NCT01175681     History of Changes
Other Study ID Numbers: ischemia
First Submitted: August 3, 2010
First Posted: August 5, 2010
Last Update Posted: July 21, 2011
Last Verified: July 2010

Keywords provided by Sun Yat-sen University:
rheumatic heart disease
degenerated heart valve disease
heart valve prolapse

Additional relevant MeSH terms:
Ischemia
Heart Valve Diseases
Pathologic Processes
Heart Diseases
Cardiovascular Diseases