Biomarkers of Aneurysm Wall Strength - Full Text View

Sponsored by:	Radboud University
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00740740

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

MedlinePlus related topics: Aneurysms

U.S. FDA Resources

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

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

Biospecimen Description:

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, Gelderland
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
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

Sponsors and Collaborators

Radboud University

Investigators

Principal Investigator:

Jan Blankensteijn

Radboud University

More Information

Responsible Party:	Radboud University Nijmegen Medical Centre ( Radboud University Nijmegen Medical Centre (M. Truijers MD) )
Study ID Numbers:	Wallstrength_01
Study First Received:	August 22, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00740740
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

Aneurysm
Rupture

Study placed in the following topic categories:

Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal
Abdominal aortic aneurysm

Vascular Diseases
Rupture
Aortic Aneurysm

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009