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

NCT01175681 | Completed DMC

• 1 other identifier: ischemia
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Valve Diseases

Keywords

rheumatic heart disease; degenerated heart valve disease; heart valve prolapse

Outcome Measures

Primary Outcomes (1)

• plasma troponin I level

  The investigators will measure the plasma troponin I level in several time points before and after surgery in each patient.

  with 7 days after surgery

Secondary Outcomes (1)

• serum creatinine

  within 7 days after surgery

Study Arms (2)

treatment

EXPERIMENTAL

remote ischaemic preconditioning

Procedure: remote ischaemic preconditioning

untreated

NO INTERVENTION

control

Interventions

remote ischaemic preconditioning 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.

treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All heart valve diseases needing heart valve surgery.

You may not qualify if:

• All four limbs existed ischemic condition

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Guangzhou First People's Hospital: collaborator

Study Sites (1)

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, 510180, China

Location

Related Publications (2)

• 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.

  PMID: 17707752 BACKGROUND

• 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.

  PMID: 22107759 DERIVED

Related Links

• Pubmed

MeSH Terms

Conditions

Heart Valve Diseases; Rheumatic Heart Disease; Heart Valve Prolapse

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Jing-song Ou, MD,PhD

  The Frist Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 5, 2010
• Study Start: December 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 21, 2011

Record last verified: 2010-07

Locations

CN (1)