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

University Hospital, Angers

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Procedure: Remote ischemic preconditioning; Procedure: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01390129

AOI 2010-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Control

Experimental group

Treatment:

Procedure: Control

Remote ischemic preconditioning

Active Comparator group

Treatment:

Procedure: Remote ischemic preconditioning