InflammationNCT02324140
Inflammatory Response in Aortic Valve Replacement
An observational study of Inflammation and Systemic Inflammatory Response Syndrome, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The study investigates inflammatory and antiinflammatory response in patients with severe aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement) or interventional cardiology treatment (transcatheter aortic valve implantation using the transfemoral access route or the transapical… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inflammation, Systemic Inflammatory Response Syndrome, Thoracic Surgery
- What is being tested?
- Whole blood analysis
- How many people
- 101 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2012to May 2015
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe aortic valve stenosis selected for surgical aortic valve replacement or transcatheter aortic valve implantation.
Who may be able to join
- Written informed consent
- Severe aortic valve stenosis
- Surgical aortic valve replacement
- Transcatheter aortic valve implantation
- No previous inflammatory condition
Who cannot join
- Missing informed consent
- Treatment with corticosteroids
- Treatment with antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Genetic Variability on Perioperative Morbidity and Mortality. Substudy: Inflammatory Response in Patients Undergoing Aortic Valve Replacement.
The study investigates inflammatory and antiinflammatory response in patients with severe aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement) or interventional cardiology treatment (transcatheter aortic valve implantation using the transfemoral access route or the transapical access route).
Read the detailed description
Background
Surgical and interventional therapy for aortic valve stenosis exposes the patients to a immune reaction, which is different depending on the type of the treatment. In this study, the investigators would like to better understand the inflammatory and antiinflammatory response in this patient population by monitoring the perioperative cytokine response (interleukins), the human leukocyte antigen expression (HLA-DR) and assessing soluble plasma factors (CD62L) involved in inflammatory processes.
Objective
Characterisation of inflammatory and antiinflammatory response in patients receiving aortic valve prosthesis selected for different treatment options.
Methods
Whole blood analysis at different time points (preoperatively, 4 / 24 /48 hours postoperatively) for different inflammatory and antiinflammatory markers: IL-6, IL-8, IL-10, CRP, TNF, soluble CD62L.
- Conditions
- Inflammation, Systemic Inflammatory Response Syndrome, Thoracic Surgery, Aortic Valve Stenosis
- Being tested
- Whole blood analysis
- Medical subject headings
- Inflammation, Systemic Inflammatory Response Syndrome, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole blood analysisOther
In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.
| Study group | Role | What they receive |
|---|---|---|
| Minimized extracorporeal circulation | Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the minimized extracorporeal circulation (MECC, group 1) Receives: Other: Whole blood analysis | |
| Conventional extracorporeal circulation | Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the conventional extracorporeal circulation (CECC, group 2) Receives: Other: Whole blood analysis | |
| Transcatheter aortic valve implantation, transfemoral access | Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transfemoral access route Receives: Other: Whole blood analysis | |
| Transcatheter aortic valve implantation, transapical access | Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transapical access route Receives: Other: Whole blood analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L)
Measured: Perioperative period ending after 48 hours postoperatively
Secondary outcomes (2)
Anti-inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-8, IL-10)
Measured: Perioperative period ending after 48 hours postoperatively
In-hospital mortality
Measured: In-hospital treatment until discharge (7-10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJun 2012
- Primary completionMar 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Stüber, MD, Prof., Study director, Dep. Anesthesiology and pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324140
- Sponsor's protocol ID
- 041/09_2
- Status last verified
- Jul 2015
- First submitted
- 15 Dec 2014
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Genetic Variability on Perioperative Morbidity and Mortality. Substudy: Inflammatory Response in Patients Undergoing Aortic Valve Replacement.
- ClinicalTrials.gov ID
- NCT02324140
- Acronym / sponsor ID
- 041/09_2
- Conditions
- Inflammation, Systemic Inflammatory Response Syndrome, Thoracic Surgery, Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Dec 2014 (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 study investigates inflammatory and antiinflammatory response in patients with severe aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement) or interventional cardiology treatment (transcatheter aortic valve implantation using the transfemoral access route or the transapical access route).
Detailed description
Background
Surgical and interventional therapy for aortic valve stenosis exposes the patients to a immune reaction, which is different depending on the type of the treatment. In this study, the investigators would like to better understand the inflammatory and antiinflammatory response in this patient population by monitoring the perioperative cytokine response (interleukins), the human leukocyte antigen expression (HLA-DR) and assessing soluble plasma factors (CD62L) involved in inflammatory processes.
Objective
Characterisation of inflammatory and antiinflammatory response in patients receiving aortic valve prosthesis selected for different treatment options.
Methods
Whole blood analysis at different time points (preoperatively, 4 / 24 /48 hours postoperatively) for different inflammatory and antiinflammatory markers: IL-6, IL-8, IL-10, CRP, TNF, soluble CD62L.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Minimized extracorporeal circulation | – | Other: Whole blood analysisPatients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the minimized extracorporeal circulation (MECC, group 1) |
| Conventional extracorporeal circulation | – | Other: Whole blood analysisPatients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the conventional extracorporeal circulation (CECC, group 2) |
| Transcatheter aortic valve implantation, transfemoral access | – | Other: Whole blood analysisPatients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transfemoral access route |
| Transcatheter aortic valve implantation, transapical access | – | Other: Whole blood analysisPatients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transapical access route |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe aortic valve stenosis selected for surgical aortic valve replacement or transcatheter aortic valve implantation.
Key inclusion criteria (5 listed)
- Written informed consent
- Severe aortic valve stenosis
- Surgical aortic valve replacement
- Transcatheter aortic valve implantation
- No previous inflammatory condition
Key exclusion criteria (3 listed)
- Missing informed consent
- Treatment with corticosteroids
- Treatment with antibiotics
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 |
|---|---|---|
| Whole blood analysisIn all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR. | Other | Conventional extracorporeal circulation, Minimized extracorporeal circulation, Transcatheter aortic valve implantation, transapical access, Transcatheter aortic valve implantation, transfemoral access |
Primary outcome
Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L)
Time frame: Perioperative period ending after 48 hours postoperatively
2 secondary outcomes
Anti-inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-8, IL-10)
Time frame: Perioperative period ending after 48 hours postoperatively
In-hospital mortality
Time frame: In-hospital treatment until discharge (7-10 days)
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 14 Jul 2015.
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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.
Frank Stüber, MD, Prof. study director
Dep. Anesthesiology and pain Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Systemic Inflammatory Response Syndrome, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 inclusion and 3 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 14 Jul 2015. 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 Switzerland. 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?
Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L) (time frame: Perioperative period ending after 48 hours postoperatively). 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 14 Jul 2015.