Back to results

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

Primary Purpose

Ischemic Heart Disease

Status

Unknown status

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

remote ischemic preconditioning

About this trial

This is an interventional prevention trial for Ischemic Heart Disease focused on measuring remote ischemic preconditioning, cognitive function, off-pump coronary artery bypass graft

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Anesthesiology and Pain Medicine, University of Ulsan, College of Medicine, Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Remote ischemic preconditioning

control

Arm Description

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

sham placement of a blood-pressure cuff around the upper limb without inflation

Outcomes

Primary Outcome Measures

cognitive function

Secondary Outcome Measures

Full Information

NCT ID

NCT00953368

First Posted

August 5, 2009

Last Updated

August 5, 2009

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00953368

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Unknown status

Study Start Date

October 2009 (undefined)

Primary Completion Date

March 2012 (Anticipated)

Study Completion Date

March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Asan Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease

Keywords

remote ischemic preconditioning, cognitive function, off-pump coronary artery bypass graft

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Remote ischemic preconditioning

Arm Type

Active Comparator

Arm Description

Arm Title

control

Arm Type

Placebo Comparator

Arm Description

sham placement of a blood-pressure cuff around the upper limb without inflation

Intervention Type

Procedure

Intervention Name(s)

remote ischemic preconditioning

Intervention Description

Primary Outcome Measure Information:

Title

cognitive function

Time Frame

preoperative, 1 week and 6 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

In-Cheol Choi, professor

Phone

+82-2-3010-3862

icchoi@amc.seoul.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Dae-Kee Choi, fellow

Phone

+82-2-3010-5633

d001109@hanmail.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

In-Cheol Choi, professor

Organizational Affiliation

Asan Medical Center, Department of Anesthesiology and Pain Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Anesthesiology and Pain Medicine, University of Ulsan, College of Medicine, Asan Medical Center

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

In-Cheol Choi, professor

Phone

+82-2-3010-3862

icchoi@amc.seoul.kr

First Name & Middle Initial & Last Name & Degree

Dae-Kee Choi, fellow

Phone

+82-2-3010-5633

d001109@hanmail.net

12. IPD Sharing Statement

Citations:

PubMed Identifier

11903027

Citation

Van Dijk D, Jansen EW, Hijman R, Nierich AP, Diephuis JC, Moons KG, Lahpor JR, Borst C, Keizer AM, Nathoe HM, Grobbee DE, De Jaegere PP, Kalkman CJ; Octopus Study Group. Cognitive outcome after off-pump and on-pump coronary artery bypass graft surgery: a randomized trial. JAMA. 2002 Mar 20;287(11):1405-12. doi: 10.1001/jama.287.11.1405.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs