Clinical Trials Directory

Trials / Completed

CompletedNCT02324140

Inflammatory Response in Aortic Valve Replacement

The Impact of Genetic Variability on Perioperative Morbidity and Mortality. Substudy: Inflammatory Response in Patients Undergoing Aortic Valve Replacement.

Status
Completed
Phase
Study type
Observational
Enrollment
101 (actual)
Sponsor
Insel Gruppe AG, University Hospital Bern · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERWhole 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.

Timeline

Start date
2012-06-01
Primary completion
2015-03-01
Completion
2015-05-01
First posted
2014-12-24
Last updated
2015-07-14

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT02324140. Inclusion in this directory is not an endorsement.