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

This study has been completed.
Sponsor:
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
History of Changes
  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
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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • serum creatinine [ Time Frame: within 7 days after surgery ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175681

Locations
China, Guangdong
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, China, 510180
Sponsors and Collaborators
Sun Yat-sen University
Guangzhou First Municipal 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:

Additional 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
Study First Received: August 3, 2010
Last Updated: July 20, 2011
Health Authority: China: Ministry of Health

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

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

ClinicalTrials.gov processed this record on June 18, 2013