Effect of Remote Preconditioning in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery
Effect of Lower Limb Remote Preconditioning on Myocardial Injury in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery
1 other identifier
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 28, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedOctober 8, 2009
October 1, 2009
4 months
April 28, 2009
October 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative serum troponin I levels
postoperatibe 1, 6, 12, 24, 48, 72 hr
Interventions
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 )
Eligibility Criteria
You may qualify if:
- Adult patients undergoing elective off pump coronary artery bypass graft surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (1)
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.
PMID: 22301846DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
YunSeok Jeon, Professor
Department of Anesthesiology and Pain Medicine, SNUH
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 28, 2009
First Posted
April 29, 2009
Study Start
March 1, 2009
Primary Completion
July 1, 2009
Study Completion
August 1, 2009
Last Updated
October 8, 2009
Record last verified: 2009-10