Biomarkers of Aneurysm Wall Strength

August 22, 2008 updated by: Radboud University Medical Center

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

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

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815AD
        • Recruiting
        • Alysis Zorggroep, Rijnstate Hospital
        • Contact:
        • Sub-Investigator:
          • Steven Sterkenburg, MD
      • Nijmegen, Gelderland, Netherlands, 6525GA
        • Recruiting
        • Radboud University Nijmegen Medical Center
        • Contact:
        • Sub-Investigator:
          • Maarten Truijers, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Tertiary care clinic. Patients scheduled for transbadominal aortic surgery

Description

Inclusion Criteria:

  • Patient scheduled for transabdominal aortic surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aneurysm wall strength
Time Frame: Post-operative
Post-operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Extra Cellular Matrix components (Glucoaminoglycans)
Time Frame: post-operative
post-operative
Biochemical blood analysis
Time Frame: post-operative
post-operative
MMP content
Time Frame: post-operative
post-operative
Degree of inflammation
Time Frame: Post-operative
Post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Jan Blankensteijn, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (Estimate)

August 25, 2008

Study Record Updates

Last Update Posted (Estimate)

August 25, 2008

Last Update Submitted That Met QC Criteria

August 22, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wallstrength_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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