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

This study has been completed.

Sponsor:

Information provided by:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT00889811

First received: April 28, 2009

Last updated: October 7, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 28, 2009

Last Updated Date

October 7, 2009

Start Date ^ICMJE

March 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

postoperative serum troponin I levels [ Time Frame: postoperatibe 1, 6, 12, 24, 48, 72 hr ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00889811 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Ischemic Heart Disease

Intervention ^ICMJE

Procedure: 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 )

Other Name: Blood pressure pneumatic cuff

Study Arm (s)

Not Provided

Publications *

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. Epub 2012 Feb 3.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00889811

Other Study ID Numbers ^ICMJE

H-0806-060-247

Has Data Monitoring Committee

Yes

Responsible Party

Jeon, YunSeok, Seoul National University Hospital

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

YunSeok Jeon, Professor

Department of Anesthesiology and Pain Medicine, SNUH

Information Provided By

Seoul National University Hospital

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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