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Biomarkers of Aneurysm Wall Strength

Sponsor
Radboud University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00740740
Collaborator
(none)
50
Enrollment
2
Locations
31
Duration (Months)
25
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed 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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Biological and Biochemical Markers of Aneurysm Wall Degradation; Towards Non-Invasive Wall Strength Analysis.
    Study Start Date :
    Jun 1, 2007
    Anticipated Primary Completion Date :
    Jan 1, 2010
    Anticipated Study Completion Date :
    Jan 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Patients scheduled for elective conventional aneurysm repair
    2

    Patients scheduled for emergent conventional aneurysm repair
    3

    Patients scheduled for aortic bypass surgery

    Outcome Measures

    Primary Outcome Measures

    1. Aneurysm wall strength [Post-operative]

    Secondary Outcome Measures

    1. Extra Cellular Matrix components (Glucoaminoglycans) [post-operative]

    2. Biochemical blood analysis [post-operative]

    3. MMP content [post-operative]

    4. Degree of inflammation [Post-operative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient scheduled for transabdominal aortic surgery
    Exclusion Criteria:

    • Patient characteristics and aneurysm anatomy suitable for endovascular repair

    • Previous aortic surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alysis Zorggroep, Rijnstate Hospital Arnhem Gelderland Netherlands 6815AD
    2 Radboud University Nijmegen Medical Center Nijmegen Gelderland Netherlands 6525GA

    Sponsors and Collaborators

    • Radboud University Medical Center

    Investigators

    • Principal Investigator: Jan Blankensteijn, Radboud University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00740740
    Other Study ID Numbers:
    • Wallstrength_01
    First Posted:
    Aug 25, 2008
    Last Update Posted:
    Aug 25, 2008
    Last Verified:
    Aug 1, 2008
    Keywords provided by , ,
    Aneurysm
    Rupture
    Additional relevant MeSH terms:
    Aneurysm
    Aortic Aneurysm
    Aortic Aneurysm, Abdominal

    Study Results

    No Results Posted as of Aug 25, 2008