Brief Title
Inflammatory Response in Aortic Valve Replacement
Official Title
The Impact of Genetic Variability on Perioperative Morbidity and Mortality. Substudy: Inflammatory Response in Patients Undergoing Aortic Valve Replacement.
Brief 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 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 Type
Observational
Primary Outcome
Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L)
Secondary Outcome
Anti-inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-8, IL-10)
Condition
Inflammation
Intervention
Whole blood analysis
Study Arms / Comparison Groups
Minimized extracorporeal circulation
Description: Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the minimized extracorporeal circulation (MECC, group 1)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
101
Start Date
June 2012
Completion Date
May 2015
Primary Completion Date
March 2015
Eligibility Criteria
Inclusion Criteria: - Written informed consent - Severe aortic valve stenosis - Surgical aortic valve replacement - Transcatheter aortic valve implantation - No previous inflammatory condition Exclusion Criteria - Missing informed consent - Treatment with corticosteroids - Treatment with antibiotics
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Frank Stüber, MD, Prof., ,
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT02324140
Organization ID
041/09_2
Responsible Party
Sponsor
Study Sponsor
University Hospital Inselspital, Berne
Study Sponsor
Frank Stüber, MD, Prof., Study Director, Dep. Anesthesiology and pain Therapy
Verification Date
July 2015