Inflammatory Response in Aortic Valve Replacement

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324140
• Other study ID #: 041/09_2
• 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

• Aortic Valve Stenosis
• Inflammation
• Systemic Inflammatory Response Syndrome
• Thoracic Surgery

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