Remote Ischemic Preconditioning in Aortic Valve Surgery

Aortic Valve Stenosis Clinical Trial

— RIP-Valve  

Official title:

Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390129
• Other study ID #: AOI 2010-07
• Status: Completed
• Phase: N/A
• First received: July 6, 2011
• Last updated: October 23, 2012
• Start date: July 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in aortic valve surgery. Infarct size will be determined by 72 hours area under curve of troponin-I.

Description:

The hypothesis tested in this research proposal is that remote ischemic preconditioning initiated immediately before aortic valve surgery reduces myocardial damage related to surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

• Aortic valve surgery for aortic stenosis

• Written informed consent

Exclusion Criteria:

• Aortic valve surgery combined with CABG or an other valve surgery

• Previous Q-wave myocardial infarction or previous coronary artery bypass graft

• Coronary artery stenosis >70%

• Ejection fraction <35%

• Surgery performed in emergency

• Nicorandil ou metformin treatment within 8 days before surgery

• Patient refusal / patient not having provided written informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Procedure:
• Control
Deflated blood pressure cuff placed on upper arm for 30min
• Remote ischemic preconditioning
Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated before aortic clamping and repeated 3 times in total

Locations

Country	Name	City	State
France	University Hospital, Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size	Infarct size as assessed by 72 hours area under curve serum troponin-I	72 hours	No