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Biomarkers of Aneurysm Wall Strength

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ClinicalTrials.gov Identifier: NCT00740740
Recruitment Status : Unknown
Verified August 2008 by Radboud University.
Recruitment status was:  Recruiting
First Posted : August 25, 2008
Last Update Posted : August 25, 2008
Sponsor:
Information provided by:
Radboud University

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
Abdominal Aortic Aneurysm

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 Type : Observational
Estimated 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 : June 2007
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Group/Cohort
1
Patients scheduled for elective conventional aneurysm repair
2
Patients scheduled for emergent conventional aneurysm repair
3
Patients scheduled for aortic bypass surgery



Primary Outcome Measures :
  1. Aneurysm wall strength [ Time Frame: Post-operative ]

Secondary Outcome Measures :
  1. Extra Cellular Matrix components (Glucoaminoglycans) [ Time Frame: post-operative ]
  2. Biochemical blood analysis [ Time Frame: post-operative ]
  3. MMP content [ Time Frame: post-operative ]
  4. Degree of inflammation [ Time Frame: Post-operative ]

Biospecimen Retention:   Samples With DNA
whole blood, serum, white cells, urine, tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Tertiary care clinic. Patients scheduled for transbadominal aortic surgery
Criteria

Inclusion Criteria:

  • Patient scheduled for transabdominal aortic surgery

Exclusion Criteria:

  • Patient characteristics and aneurysm anatomy suitable for endovascular repair
  • Previous aortic surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740740


Contacts
Contact: Maarten Truijers, MD 0031-24-3615333 M.Truijers@chir.umcn.nl

Locations
Netherlands
Alysis Zorggroep, Rijnstate Hospital Recruiting
Arnhem, Gelderland, Netherlands, 6815AD
Contact: Steven Sterkenburg, MD    0031-88-005 8888    SvanSterkenburg@alysis.nl   
Sub-Investigator: Steven Sterkenburg, MD         
Radboud University Nijmegen Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6525GA
Contact: Maarten Truijers, MD    0031-24-3615333    m.truijers@chir.umcn.nl   
Sub-Investigator: Maarten Truijers, MD         
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Jan Blankensteijn Radboud University

Responsible Party: Radboud University Nijmegen Medical Centre (M. Truijers MD), Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00740740     History of Changes
Other Study ID Numbers: Wallstrength_01
First Posted: August 25, 2008    Key Record Dates
Last Update Posted: August 25, 2008
Last Verified: August 2008

Keywords provided by Radboud University:
Aneurysm
Rupture

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases