Aortic Valve Stenosis
Conditions
Brief 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.
Detailed 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.
Interventions
PROCEDUREControl
Deflated blood pressure cuff placed on upper arm for 30min
PROCEDURERemote 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
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct size | 72 hours | Infarct size as assessed by 72 hours area under curve serum troponin-I |
Countries
France
Outcome results
None listed