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NCT Number: NCT00889811

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ischemic preconditioning

Procedure

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 names: Blood pressure pneumatic cuff

Primary outcomes

  1. postoperative serum troponin I levels

    Time frame: postoperatibe 1, 6, 12, 24, 48, 72 hr

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 29, 2009
Registry last updated
Oct 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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