NCT00740740

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2007

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 25, 2008

Status Verified

August 1, 2008

Enrollment Period

2.6 years

First QC Date

August 22, 2008

Last Update Submit

August 22, 2008

Conditions

Abdominal Aortic Aneurysm

Keywords

AneurysmRupture

Outcome Measures

Primary Outcomes (1)

  • Aneurysm wall strength

    Post-operative

Secondary Outcomes (4)

  • Extra Cellular Matrix components (Glucoaminoglycans)

    post-operative

  • Biochemical blood analysis

    post-operative

  • MMP content

    post-operative

  • Degree of inflammation

    Post-operative

Study Arms (3)

1

Patients scheduled for elective conventional aneurysm repair

2

Patients scheduled for emergent conventional aneurysm repair

3

Patients scheduled for aortic bypass surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Tertiary care clinic. Patients scheduled for transbadominal aortic surgery

You may qualify if:

  • Patient scheduled for transabdominal aortic surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alysis Zorggroep, Rijnstate Hospital

Arnhem, Gelderland, 6815AD, Netherlands

RECRUITING

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, urine, tissue

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalAneurysmRupture

Condition Hierarchy (Ancestors)

Aortic AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesWounds and Injuries

Study Officials

  • Jan Blankensteijn

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maarten Truijers, MD

CONTACT

0031-24-3615333M.Truijers@chir.umcn.nl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2008

First Posted

August 25, 2008

Study Start

June 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 25, 2008

Record last verified: 2008-08

Locations

NL(2)