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Effect of Remote Preconditioning in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery

Primary Purpose

Ischemic Heart Disease

Status

Completed

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 OPCAB, RIPC

Eligibility Criteria

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

Inclusion Criteria:

Adult patients undergoing elective off pump coronary artery bypass graft surgery

Exclusion Criteria:

unstable angina
preoperative use of inotropics or mechanical assist device,
left ventricular ejection fraction less than 30%,
major combined operation such as aortic surgery or carotid endarterectomy,
severe liver, renal and pulmonary disease,
recent myocardial infarction (within 7 days),
recent systemic infection or sepsis (within 7 days)
peripheral vascular disease affecting lower limbs
amputation of the lower limbs

Sites / Locations

Seoul National University Hospital

Outcomes

Primary Outcome Measures

postoperative serum troponin I levels

Secondary Outcome Measures

Full Information

NCT ID

NCT00889811

First Posted

April 28, 2009

Last Updated

October 7, 2009

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00889811

Brief Title

Effect of Remote Preconditioning in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery

Official Title

Effect of Lower Limb Remote Preconditioning on Myocardial Injury in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In recent several clinical trials, remote preconditioning showed very powerful myocardial protection. However, the myocardial protective effect by remote preconditioning was not evaluated on the patients undergoing off pump coronary artery bypass graft surgery (OPCAB). The investigators hypothesized that the lower limb remote preconditioning could protect the myocardium during the OPCAB. In this study, the investigators will try to evaluate whether remote preconditioning could induce myocardial protection on the OPCAB patients.

Detailed Description

In recent two clinical trials on the patients undergoing cardiac surgery, remote preconditioning showed very powerful myocardial protection by simple and safe procedures such as the brief inflation of pneumatic tourniquet on the upper or lower limb. However, despite these impressive results, the clinical studies are lacking yet. Moreover, two previous studies were done on the cardiac surgery with cardiopulmonary bypass. Considering different mechanism, level of myocardial injury and the increasing popularity of OPCAB, we need the clinical study on remote preconditioning with the OPCAB patients. In this study, we will conduct randomized controlled clinical trials in which the remote preconditioning was induced by lower limb ischemia with double-blinded technique. Myocardial injury will be assessed by postoperative serum troponin I levels and they will be compared with those of control group.

6. Conditions and Keywords

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

Ischemic Heart Disease

Keywords

OPCAB, RIPC

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

remote ischemic preconditioning

Other Intervention Name(s)

Blood pressure pneumatic cuff

Intervention Description

remote ischemic preconditioning (4 x 5 min lower limb ischemia with pneumatic cuff up to 200 mmHg with an intervening 5 min reperfusion; 2 cycles; before and after the coronary anastomosis )

Primary Outcome Measure Information:

Title

postoperative serum troponin I levels

Time Frame

postoperatibe 1, 6, 12, 24, 48, 72 hr

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients undergoing elective off pump coronary artery bypass graft surgery Exclusion Criteria: unstable angina preoperative use of inotropics or mechanical assist device, left ventricular ejection fraction less than 30%, major combined operation such as aortic surgery or carotid endarterectomy, severe liver, renal and pulmonary disease, recent myocardial infarction (within 7 days), recent systemic infection or sepsis (within 7 days) peripheral vascular disease affecting lower limbs amputation of the lower limbs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

YunSeok Jeon, Professor

Organizational Affiliation

Department of Anesthesiology and Pain Medicine, SNUH

Official's Role

Study Director

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

22301846

Citation

Hong DM, Jeon Y, Lee CS, Kim HJ, Lee JM, Bahk JH, Kim KB, Hwang HY. Effects of remote ischemic preconditioning with postconditioning in patients undergoing off-pump coronary artery bypass surgery--randomized controlled trial. Circ J. 2012;76(4):884-90. doi: 10.1253/circj.cj-11-1068. Epub 2012 Feb 3.

Results Reference

derived

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Effect of Remote Preconditioning in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery

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