Aortic Valve DiseaseNCT02694016
Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery
A study testing Remote ischemic preconditioning in people with Aortic Valve Disease and Myocardial Ischemia, run by Oulu University Hospital at 1 site in Finland.
Trial summary
The goal is to investigate the efficacy, safety and possible neuro- and cardioprotective effects of remote ischemic preconditioning (RIPC) in adult cardiac patients undergoing isolated aortic valve replacement surgery with a biological prosthesis. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Aortic Valve Disease, Myocardial Ischemia
- 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
- 4 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2016to Dec 2017
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-emergency aortic valve replacement with a biological prosthesis with perfusion and cardiac arrest
Who cannot join
- Recent myocardial infarction
- Carotid stenosis requiring intervention
- Any other concomitant surgical procedure
- Increased troponin baseline before surgery
- Critical ischemia of lower limbs
- Peripheral arterial disease (ASO, media sclerosis)
Show all 12Show fewer
- Morbid obesity (Incompatible cuff-to-thigh diameter)
- Severe heart insufficiency
- Moderate to severe venous insufficiency lower limbs
- Recent acute stroke <90d
- Difference in cardioplegic protocol
- Diseased aorta in epiaortic ultrasound
Trial locations and contacts
1 site in 1 country.
Finland1 site
Oulu University Hospital, Department of Cardiothoracic surgery
Oulu, 900220
About this study
Official title: Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery With a Biological Prosthesis: A Single Center Randomized Prospective Study
The goal is to investigate the efficacy, safety and possible neuro- and cardioprotective effects of remote ischemic preconditioning (RIPC) in adult cardiac patients undergoing isolated aortic valve replacement surgery with a biological prosthesis. Neuropsychological evaluation preoperatively and at 30d after surgery will establish if there are any differences in neuropsychological performance between groups. A large array of biochemical markers will be analyzed from plasma samples taken at different time points. Additionally skin biopsies from the lower limb will be taken before and after performing RIPC on said limb. During the venous cannulation phase a atrial biopsy will be taken. The biochemical markers from plasma and tissue samples will be used to asses brain tissue damage, inflammation and cardiac tissue damage between groups.
This will be a single center prospective randomized study with two groups. A intervention group (RIPC) and a control group. Study size is: 40 patients in total, 20 patients per group.
- Conditions
- Aortic Valve Disease, Myocardial Ischemia
- Being tested
- Remote ischemic preconditioning
- Keywords
- Remote ischemic preconditioning, Neuroprotection
- Medical subject headings
- Aortic Valve Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningProcedure or surgery
A blood pressure cuff is placed around the right leg on the level of the thigh. Randomization is performed after this, using sealed envelopes with covariate balancing for age and sex. Regardless of the outcome of the randomization the cuff is left in place so as not to give any indication of which group the patient belongs to. If the patient is randomized into the remote ischemic preconditioning group (RIPC) then four (4) cycles of five (5) minute inflation are given after induction. Each cycle is followed by a five (5) minute interval of reperfusion. Cuff pressure should be 200mgHg at least (RRsyt + 100mmgHg) during the inflation periods.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic preconditioning | Experimental | Patient will undergo normal isolated aortic valve replacement surgery with a biological prosthesis and a preoperative lower leg remote ischemic preconditioning(RIPC) phase. Receives: Procedure: Remote ischemic preconditioning |
| Control group | No intervention | Patient will undergo normal isolated aortic valve replacement surgery with a biological prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological assesment
Investigators will use a neuropsychological test battery to test our subject pre- and post-operatively. A qualified psychologist will administer the test battery. The test battery will be relatively simple but still have several different tests. These tests will include but are not limited to:
- Trail Making test A \& B (TMT)
Measured: 1 month postoperatively
Neuropsychological assesment
Digit Span test
Measured: 1 month postoperatively
Neuropsychological assesment
Rey Auditory Verbal Learning Test (RAVLT)
Measured: 1 month postoperatively
Secondary outcomes (2)
Inflammation markers analysed from plasma and tissue samples
A bioplex/multiplex assay of systemic inflammatory response markers and other cytokines including but not limited to:
Tumor Necrosis Factor-a, Interleukin-1b, -2, -4, -5, -6. C-Reactive Protein, Hypoxia inducible Factor -1.
Measured: A day before surgery, during surgery, 24hour and 48hour postoperatively
Tissue specific markers analysed from plasma
A bioplex/multiplex assay of neuronal and cardiac tissue specific biomarkers including but not limited to:
S-100b, Glial Fibrillary acidic protein, Neuron Specific enolase, Troponin-I, Brain Natriuretic Peptide, Creatinine Kinase - MB
Measured: A day before surgery, during surgery, 24hour and 48hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Insufficient recruitment pace
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik Yannopoulos, Oulu University Hospital
- Investigators
- Fredrik Yannopoulos, MD Ph.D, Study director, Oulu University HospitalVesa Anttila, MD Ph.D., Study chair, Oulu University HospitalTuomas Ahvenvaara, MD, Principal investigator, Oulu University HospitalTuomas Mäkelä, MD.Ph.D., Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694016
- Sponsor's protocol ID
- RIPC00AVR
- Status last verified
- Apr 2018
- First submitted
- 18 Feb 2016
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery With a Biological Prosthesis: A Single Center Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT02694016
- Acronym / sponsor ID
- RIPC00AVR
- Conditions
- Aortic Valve Disease, Myocardial Ischemia
- Keywords
- Remote ischemic preconditioning, Neuroprotection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment pace
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Feb 2016 (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.
The goal is to investigate the efficacy, safety and possible neuro- and cardioprotective effects of remote ischemic preconditioning (RIPC) in adult cardiac patients undergoing isolated aortic valve replacement surgery with a biological prosthesis. Neuropsychological evaluation preoperatively and at 30d after surgery will establish if there are any differences in neuropsychological performance between groups. A large array of biochemical markers will be analyzed from plasma samples taken at different time points. Additionally skin biopsies from the lower limb will be taken before and after performing RIPC on said limb. During the venous cannulation phase a atrial biopsy will be taken. The biochemical markers from plasma and tissue samples will be used to asses brain tissue damage, inflammation and cardiac tissue damage between groups.
This will be a single center prospective randomized study with two groups. A intervention group (RIPC) and a control group. Study size is: 40 patients in total, 20 patients per group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic preconditioning | Experimental | Procedure: Remote ischemic preconditioningPatient will undergo normal isolated aortic valve replacement surgery with a biological prosthesis and a preoperative lower leg remote ischemic preconditioning(RIPC) phase. |
| Control group | No intervention | –Patient will undergo normal isolated aortic valve replacement surgery with a biological prosthesis |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-emergency aortic valve replacement with a biological prosthesis with perfusion and cardiac arrest
Key exclusion criteria (12 listed)
- Recent myocardial infarction
- Carotid stenosis requiring intervention
- Any other concomitant surgical procedure
- Increased troponin baseline before surgery
- Critical ischemia of lower limbs
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 |
|---|---|---|
| Remote ischemic preconditioningA blood pressure cuff is placed around the right leg on the level of the thigh. Randomization is performed after this, using sealed envelopes with covariate balancing for age and sex. Regardless of the outcome of the randomization the cuff is left in place so as not to give any indication of which group the patient belongs to. If the patient is randomized into the remote ischemic preconditioning group (RIPC) then four (4) cycles of five (5) minute inflation are given after induction. Each cycle is followed by a five (5) minute interval of reperfusion. Cuff pressure should be 200mgHg at least (RRsyt + 100mmgHg) during the inflation periods. | Procedure or surgery | Remote ischemic preconditioning |
Primary outcome
Neuropsychological assesment
Time frame: 1 month postoperatively
Investigators will use a neuropsychological test battery to test our subject pre- and post-operatively. A qualified psychologist will administer the test battery. The test battery will be relatively simple but still have several different tests. These tests will include but are not limited to: - Trail Making test A \& B (TMT)
Neuropsychological assesment
Time frame: 1 month postoperatively
Digit Span test
Neuropsychological assesment
Time frame: 1 month postoperatively
Rey Auditory Verbal Learning Test (RAVLT)
2 secondary outcomes
Inflammation markers analysed from plasma and tissue samples
Time frame: A day before surgery, during surgery, 24hour and 48hour postoperatively
Tissue specific markers analysed from plasma
Time frame: A day before surgery, during surgery, 24hour and 48hour postoperatively
Results and safety
The study was stopped early (reason given: Insufficient recruitment pace). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- 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.
Fredrik Yannopoulos, MD Ph.D study director
Oulu University Hospital
Vesa Anttila, MD Ph.D. study chair
Oulu University Hospital
Tuomas Ahvenvaara, MD principal investigator
Oulu University Hospital
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 Disease and Myocardial Ischemia, run by Oulu University Hospital at 1 site in Finland.
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 1 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 Apr 2018. 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 Finland. 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 was stopped early (reason given: Insufficient recruitment pace). 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?
Neuropsychological assesment (time frame: 1 month postoperatively). The study lists 3 primary outcomes in all. 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 4 Apr 2018.