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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02324140
Other study ID # 041/09_2
Secondary ID
Status Completed
Phase N/A
First received December 15, 2014
Last updated July 13, 2015
Start date June 2012
Est. completion date May 2015

Study information

Verified date July 2015
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical 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 access route).


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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date May 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Whole blood analysis
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.

Locations

Country Name City State
Switzerland Dep. Anesthesiology and Pain Therapy Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L) Perioperative period ending after 48 hours postoperatively No
Secondary Anti-inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-8, IL-10) Perioperative period ending after 48 hours postoperatively No
Secondary In-hospital mortality In-hospital treatment until discharge (7-10 days) No
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