Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery

NCT ID: NCT01175681

Last Updated: 2011-07-21

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

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-06-30

Brief Summary

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Remote ischaemic preconditioning has shown its cardiac protective effect during heart surgery including coronary artery bypass graft surgery, congenital heart disease and aneurysm. However, no data was reported on heart valve disease surgery. Rheumatic heart disease is one of the major heart diseases requiring surgery in China. Thus, the investigators chose heart valve disease as a focus to see whether remote ischaemic preconditioning also has cardiac protective effect during heart valve surgery.

Detailed Description

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Conditions

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Heart Valve Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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treatment

remote ischaemic preconditioning

Group Type EXPERIMENTAL

remote ischaemic preconditioning

Intervention Type PROCEDURE

Remote ischaemic preconditioning consisted of three 5-min cycles of right upper arm ischaemia, which was induced by an automated cuff -inflator placed on the right upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated. There was a 5- to 10-min interval between completion of the remote ischaemic preconditioning protocol and initiation of bypass.Control patients had a deflated cuff placed on the right upper arm for 30 min.

untreated

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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remote ischaemic preconditioning

Remote ischaemic preconditioning consisted of three 5-min cycles of right upper arm ischaemia, which was induced by an automated cuff -inflator placed on the right upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated. There was a 5- to 10-min interval between completion of the remote ischaemic preconditioning protocol and initiation of bypass.Control patients had a deflated cuff placed on the right upper arm for 30 min.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All heart valve diseases needing heart valve surgery.

Exclusion Criteria

* All four limbs existed ischemic condition
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou First People's Hospital

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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The First Affiliated Hospital, Sun Yat-sen University.

Principal Investigators

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Jing-song Ou, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Frist Affiliated Hospital, Sun Yat-sen University

Locations

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Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.

Reference Type BACKGROUND
PMID: 17707752 (View on PubMed)

Xie JJ, Liao XL, Chen WG, Huang DD, Chang FJ, Chen W, Luo ZL, Wang ZP, Ou JS. Remote ischaemic preconditioning reduces myocardial injury in patients undergoing heart valve surgery: randomised controlled trial. Heart. 2012 Mar;98(5):384-8. doi: 10.1136/heartjnl-2011-300860. Epub 2011 Nov 22.

Reference Type DERIVED
PMID: 22107759 (View on PubMed)

Related Links

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Other Identifiers

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ischemia

Identifier Type: -

Identifier Source: org_study_id

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