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

Fudan University logo

Fudan University

Status

Unknown

Conditions

OPCABG

Treatments

Other: RIPC

Study type

Interventional

Funder types

Other

Identifiers

NCT03340181
B2017-100R

Details and patient eligibility

About

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

Full 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.

Enrollment

66 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 2 patient groups

RIPC
Experimental group
Description:
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.
Treatment:
Other: RIPC
control
Sham Comparator group
Description:
patient in control group using a blood pressure cuff on an upper limb without inflating
Treatment:
Other: RIPC

Trial contacts and locations

1

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Central trial contact

Ke-fang Guo, Phd

Data sourced from clinicaltrials.gov

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