Study on the Myocardial Protective Effect of Upper Limb Ischemic Preconditioning in Patients Undergoing Off-pump Coronary Artery Bypass Grafting

Not Applicable

• Conditions: OPCABG
• Interventions: Other: RIPC

• Registration Number: NCT03340181
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

The purpose of the study was to verify the myocardial protective effect of RIPC in patients undergoing OPCABG.

Detailed Description

66 patients scheduled for OPCABG are randomly assigned to a RIPC group(n=33) or a control group(n=33). In the RIPC group, 4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmHg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb before skin incision. Patients in the control group wear the same cuff on an upper limb but no pressure is applied. Anesthetic and surgical techniques are standardized during the trial. Serum inflammatory cytokines and cardiac injury markers will be measured before and after surgery. Internal mammary artery and saphenous vein tissues will be collected during the surgery to assess hypoxia-inducible factor (Hif)-1a and other signalling proteins.

Study Timeline

• Study First Submitted: 2017-10-31
• Status Verified: 2017-11
• Study Start: 2017-11-01
• Study First Submitted QC: 2017-11-08
• Last Update Submitted: 2017-11-08
• Study First Posted: 2017-11-13
• Last Update Posted: 2017-11-13
• Primary Completion: 2019-03-31
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• serious changes in several coronary arteries that need to receive OPCABG
• NHYA II-III
• ASA II-III

Exclusion Criteria

• LVEF< 35%
• acute myocardial infarction
• multiple organ dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	RIPC	patient in control group using a blood pressure cuff on an upper limb without inflating
RIPC	RIPC	4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmHg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb.

Primary Outcome Measures

Name	Time	Method
ICU staying time	average of 1 year	the time patients spend in ICU after surgery

Trial Locations

Locations (1)

Huilin Wang; 🇨🇳 Shanghai, Shanghai, China