Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
35 participants
OBSERVATIONAL
2007-10-31
2008-12-31
Brief Summary
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Objective: Correlation of FDG uptake and in vitro aneurysm wall tensile strength. (primary objective). The effect of aneurysm sac depressurisation, after endovascular aneurysm repair, on aneurysm wall inflammation (secondary objective).
Study design: Observational case series (pilot). Study population: Patients scheduled for conventional (open) and endovascular aneurysm repair.
Main study parameters: Standard uptake value (SUV) measurements to asses FDG uptake in the aneurysm wall and in vitro aneurysm wall strength (N/mm).
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Patients scheduled for conventional (open) or endovascular aneurysm repair are admitted to the hospital the day before surgery. At that point all patients will be evaluated using FDG-PET. Although intake of sugar-free liquids is permitted, glucose intake is restricted 6 hours prior to FDG-PET imaging. One hour after intravenous injection of 200-220 MBq FDG, whole body emission and transmission images will be acquired. To determine inflammation markers ( e.g. CRP), blood and urine samples will be collected prior to the operation and again 6 weeks after surgery. For in vitro aneurysm wall tensile strength testing wall specimens will be harvested during conventional aneurysm repair.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1
Patients scheduled for conventional aneurysm repair
No interventions assigned to this group
2
Patients scheduled for endovascular aneurysm repair
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Informed consent
Exclusion Criteria
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Radboud University Nijmegen Medical Centre
Principal Investigators
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Maarten Truijers, MD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Maarten Truijers, MD
Role: primary
Other Identifiers
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ASAP
Identifier Type: -
Identifier Source: org_study_id