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

NCT ID: NCT00889811

Last Updated: 2009-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-08-31

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.

Conditions

Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Interventions

remote ischemic preconditioning

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 )

Intervention Type: PROCEDURE

Other Intervention Names

Blood pressure pneumatic cuff

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoul National University Hospital

Principal Investigators

YunSeok Jeon, Professor

Role: STUDY_DIRECTOR

Department of Anesthesiology and Pain Medicine, SNUH

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 22301846 (View on PubMed)

Other Identifiers

H-0806-060-247

Identifier Type: -

Identifier Source: org_study_id