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NCT00740740 Clinical Trial

Biomarkers of Aneurysm Wall Strength

Abdominal Aortic Aneurysm Clinical Trial

Official title:
Biological and Biochemical Markers of Aneurysm Wall Degradation; Towards Non-Invasive Wall Strength Analysis.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00740740
Other study ID # Wallstrength_01
Secondary ID
Status Recruiting
Phase N/A
First received August 22, 2008
Last updated August 22, 2008
Start date June 2007
Est. completion date January 2010

Study information
Verified date August 2008
Source Radboud University
Contact Maarten Truijers, MD
Phone 0031-24-3615333
Email M.Truijers@chir.umcn.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial Summary

The purpose of this study is to identify possible in vivo biochemical and biological markers related to aortic wall strength.

Description:

Rupture of an Abdominal Aortic Aneurysm (AAA) is potentially lethal. prophylactic surgical repair is therefore warranted when the risk of rupture exceeds the risk of complications following surgery. Aneurysm rupture occurs when the forces (stress) acting on the aneurysm wall surpass aneurysm wall strength. Information on both wall stress and strength might therefore improve rupture risk assessment and patient selection for prophylactic repair. Although aneurysm wall stress calculations are possible, no in vivo method exists to determine aneurysm wall strength. This study was designed to identify possible biomarkers of aneurysm wall strength

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient scheduled for transabdominal aortic surgery

Exclusion Criteria:

- Patient characteristics and aneurysm anatomy suitable for endovascular repair

- Previous aortic surgery

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Alysis Zorggroep, Rijnstate Hospital Arnhem Gelderland
Netherlands Radboud University Nijmegen Medical Center Nijmegen Gelderland

Sponsors (1)
Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Aneurysm wall strength Post-operative No
Secondary Extra Cellular Matrix components (Glucoaminoglycans) post-operative No
Secondary Biochemical blood analysis post-operative No
Secondary MMP content post-operative No
Secondary Degree of inflammation Post-operative No
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