Aortic Valve StenosisRIP-ValveNCT01390129
Remote Ischemic Preconditioning in Aortic Valve Surgery
A study testing Remote ischemic preconditioning in people with Aortic Valve Stenosis, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Aortic valve surgery for aortic stenosis
- Written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)
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.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Control, Remote ischemic preconditioning
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlProcedure or surgery
Deflated blood pressure cuff placed on upper arm for 30min
Remote ischemic preconditioningProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Not described Receives: Procedure: Control |
| Remote ischemic preconditioning | Active comparator | Not described Receives: Procedure: Remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size
Infarct size as assessed by 72 hours area under curve serum troponin-I
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fabrice Prunier, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390129
- Sponsor's protocol ID
- AOI 2010-07
- Acronym
- RIP-Valve
- Status last verified
- Oct 2012
- First submitted
- 6 Jul 2011
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27664804
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)
- ClinicalTrials.gov ID
- NCT01390129
- Acronym / sponsor ID
- RIP-Valve / AOI 2010-07
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jul 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Procedure: Control |
| Remote ischemic preconditioning | Active comparator | Procedure: Remote ischemic preconditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- Aortic valve surgery for aortic stenosis
- Written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlDeflated blood pressure cuff placed on upper arm for 30min | Procedure or surgery | Control |
| Remote ischemic preconditioningBlood 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 | Procedure or surgery | Remote ischemic preconditioning |
Primary outcome
Infarct size
Time frame: 72 hours
Infarct size as assessed by 72 hours area under curve serum troponin-I
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
- Derived from this study: PubMed 27664804Chao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice Prunier, MD, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning in people with Aortic Valve Stenosis, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01390129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012.