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Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Asan Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00953368
First received: August 5, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

The aim of this study is to evaluate the effects of remote ischemic preconditioning on cognitive function in patients undergoing off-pump coronary artery bypass graft.


Condition Intervention Phase
Ischemic Heart Disease
 Procedure: remote ischemic preconditioning
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • cognitive function [ Time Frame: preoperative, 1 week and 6 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: October 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Remote ischemic preconditioning
Remote ischemic preconditioning will be induced by four 5-min cycles of upper limb ischemia and 5-min reperfusion with a blood-pressure cuff inflated to 200 mmHg and be performed before and after the coronary anastomosis
 Procedure: remote ischemic preconditioning
Remote ischemic preconditioning will be induced by four 5-min cycles of upper limb ischemia and 5-min reperfusion with a blood-pressure cuff inflated to 200 mmHg and be performed before and after the coronary anastomosis
Placebo Comparator: control
sham placement of a blood-pressure cuff around the upper limb without inflation
 Procedure: remote ischemic preconditioning
Remote ischemic preconditioning will be induced by four 5-min cycles of upper limb ischemia and 5-min reperfusion with a blood-pressure cuff inflated to 200 mmHg and be performed before and after the coronary anastomosis

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective off-pump coronary artery bypass graft surgery

Exclusion Criteria:

  • Emergency operation
  • Preoperative use of inotropic drugs or mechanical assistant device
  • Ejection fraction less than 30%
  • Combined operation using CPB such as valve surgery
  • Previous psychiatric and neurologic disorder
  • Inability to perform the cognitive function test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953368

Contacts
Contact: In-Cheol Choi, professor +82-2-3010-3862 icchoi@amc.seoul.kr
Contact: Dae-Kee Choi, fellow +82-2-3010-5633 d001109@hanmail.net

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, University of Ulsan, College of Medicine, Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of, 138-736
Contact: In-Cheol Choi, professor     +82-2-3010-3862     icchoi@amc.seoul.kr    
Contact: Dae-Kee Choi, fellow     +82-2-3010-5633     d001109@hanmail.net    
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: In-Cheol Choi, professor Asan Medical Center, Department of Anesthesiology and Pain Medicine
  More Information

Publications:

Responsible Party: In-Cheol Choi, professor, Asan Medical Center, Department of Anesthesiology and Pain Medicine
ClinicalTrials.gov Identifier: NCT00953368     History of Changes
Other Study ID Numbers: RIPC-3862
Study First Received: August 5, 2009
Last Updated: August 5, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
remote ischemic preconditioning
cognitive function
off-pump coronary artery bypass graft

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Coronary Disease
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013