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

NCT ID: NCT03340181

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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OPCABG

Keywords

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RIPC, myocardial protective effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

RIPC

Intervention Type OTHER

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.

control

patient in control group using a blood pressure cuff on an upper limb without inflating

Group Type SHAM_COMPARATOR

RIPC

Intervention Type OTHER

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.

Interventions

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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 before skin incision.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hui-lin Wang, Phd

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Huilin Wang

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ke-fang Guo, Phd

Role: CONTACT

Phone: 021-64041990

Email: [email protected]

Facility Contacts

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Wang Huilin, PH.D

Role: primary

Other Identifiers

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B2017-100R

Identifier Type: -

Identifier Source: org_study_id