Aortic Valve StenosisNCT03305094
The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery
A study testing Blood pressure cuff inflation in people with Aortic Valve Stenosis and Cardiopulmonary Bypass, run by Laval University at 1 site in Canada.
Trial summary
The study objective is to verify if a non-invasive remote ischemic preconditioning procedure (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve replacement surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Cardiopulmonary Bypass
- What is being tested?
- Blood pressure cuff inflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 11 Apr 2014to 1 Dec 2024
- 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
- Planned isolated aortic valve replacement (stenosis based)
- Age ≥ 18 years
Who cannot join
- Pregnancy
- Left ventricular dysfunction (LVEF< 50%)
- Myocardial Infarct (< 7days)
- Coronary artery disease (documented with >50% stenosis)
- Coronary artery bypass grafting
- Chronic renal insufficiency (creatinine >175 mmol/L or dialysis)
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- Endocarditis
- Sternotomy redo
- Deep vein thrombosis to the compressed limb
- Emergency procedure
- TAVI procedure
- Planned off pump coronary artery bypass
- MAZE procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery : a Randomized Controlled Trial
The study objective is to verify if a non-invasive remote ischemic preconditioning procedure (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve replacement surgery.
- Conditions
- Aortic Valve Stenosis, Cardiopulmonary Bypass
- Being tested
- Blood pressure cuff inflation
- Keywords
- Remote ischemic preconditioning, Myocardial infarction, Cardiac surgery
- Medical subject headings
- Aortic Valve Stenosis, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure cuff inflationProcedure or surgery
Cuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Sham remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 20 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The sham ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass.
A 20 mm Hg blood pressure cuff on the right arm does not induce ischemia. Receives: Procedure: Blood pressure cuff inflation |
| Intervention group | Experimental | Remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 200 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass. Receives: Procedure: Blood pressure cuff inflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biochemical markers of myocardial ischemia
Troponin T-HS and CK-MB concentration
Measured: 6, 12, 24 and 48 hours post-operatively
Secondary outcomes (1)
Post-operative complications
Monitoring the safety of the strategy by monitoring post-operative complications
Measured: post-operatively until 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start11 Apr 2014
- Primary completion1 Jul 2020
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Randomized controlled prospective trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Responsible party
- Principal investigator, Pierre Voisine, Laval University
- Investigators
- Pierre Voisine, MD, Principal investigator, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305094
- Sponsor's protocol ID
- CONDOR-21082
- Status last verified
- Mar 2023
- First submitted
- 28 Sep 2017
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03305094
- Acronym / sponsor ID
- CONDOR-21082
- Conditions
- Aortic Valve Stenosis, Cardiopulmonary Bypass
- Keywords
- Remote ischemic preconditioning, Myocardial infarction, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Study start
- 11 Apr 2014 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 9 Oct 2017 (actual)
- 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.
The study objective is to verify if a non-invasive remote ischemic preconditioning procedure (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve replacement surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled prospective trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Blood pressure cuff inflationSham remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 20 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The sham ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass. A 20 mm Hg blood pressure cuff on the right arm does not induce ischemia. |
| Intervention group | Experimental | Procedure: Blood pressure cuff inflationRemote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 200 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned isolated aortic valve replacement (stenosis based)
- Age ≥ 18 years
Key exclusion criteria (13 listed)
- Pregnancy
- Left ventricular dysfunction (LVEF< 50%)
- Myocardial Infarct (< 7days)
- Coronary artery disease (documented with >50% stenosis)
- Coronary artery bypass grafting
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 |
|---|---|---|
| Blood pressure cuff inflationCuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg | Procedure or surgery | Control group, Intervention group |
Primary outcome
Change in biochemical markers of myocardial ischemia
Time frame: 6, 12, 24 and 48 hours post-operatively
Troponin T-HS and CK-MB concentration
1 secondary outcome
Post-operative complications
Time frame: post-operatively until 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Pierre Voisine, MD principal investigator
University Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure cuff inflation in people with Aortic Valve Stenosis and Cardiopulmonary Bypass, run by Laval University at 1 site in Canada.
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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 10 Mar 2023. 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 Canada. 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?
Results are not available in the source record.
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?
Change in biochemical markers of myocardial ischemia (time frame: 6, 12, 24 and 48 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2023.