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Biomarkers of Aneurysm Wall Strength

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00740740
First received: August 22, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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


Condition
Abdominal Aortic Aneurysm

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Biological and Biochemical Markers of Aneurysm Wall Degradation; Towards Non-Invasive Wall Strength Analysis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Aneurysm wall strength [ Time Frame: Post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Extra Cellular Matrix components (Glucoaminoglycans) [ Time Frame: post-operative ] [ Designated as safety issue: No ]
  • Biochemical blood analysis [ Time Frame: post-operative ] [ Designated as safety issue: No ]
  • MMP content [ Time Frame: post-operative ] [ Designated as safety issue: No ]
  • Degree of inflammation [ Time Frame: Post-operative ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, white cells, urine, tissue


Estimated Enrollment: 50
Study Start Date: June 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients scheduled for elective conventional aneurysm repair
2
Patients scheduled for emergent conventional aneurysm repair
3
Patients scheduled for aortic bypass surgery

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 22, 2008
Last Updated: August 22, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Aneurysm
Rupture

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

ClinicalTrials.gov processed this record on May 23, 2013