Remote Ischemic Preconditioning in Aortic Valve Surgery
RIP-Valve
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 6, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 24, 2012
October 1, 2012
1.3 years
July 6, 2011
October 23, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Infarct size
Infarct size as assessed by 72 hours area under curve serum troponin-I
72 hours
Study Arms (2)
Control
EXPERIMENTALRemote ischemic preconditioning
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- Age \> 18
- Aortic valve surgery for aortic stenosis
- Written informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, Angers
Angers, 49933, France
Related Publications (1)
Chao de la Barca JM, Bakhta O, Kalakech H, Simard G, Tamareille S, Catros V, Callebert J, Gadras C, Tessier L, Reynier P, Prunier F, Mirebeau-Prunier D. Metabolic Signature of Remote Ischemic Preconditioning Involving a Cocktail of Amino Acids and Biogenic Amines. J Am Heart Assoc. 2016 Sep 24;5(9):e003891. doi: 10.1161/JAHA.116.003891.
PMID: 27664804DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabrice Prunier, MD, PhD
University Hospital, Angers
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2011
First Posted
July 8, 2011
Study Start
July 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
October 24, 2012
Record last verified: 2012-10