To identify possible in vivo biochemical and biological markers related to aneurysm wall strength.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Aneurysm wall tensile strength (N/mm).
2. Concentration of biodegrading enzymes in the aneurysm wall (arbitrary units
per milligram proteins).
3. The presence of specific glucosaminoglycans in the AAA wall and in patients
blood and urine.
4. Drop in relative MR signal intensity on USPIO enhanced MR imaging
(macrophage detection).
5. Histological presence of macrophages (field count).
Secondary outcome
1. Aneurysm diameter
Background summary
Since rupture of an Abdominal Aortic Aneurysm (AAA) is potentially lethal,
prophylactic surgical repair is warranted when the risk of rupture exceeds the
risk of complications following surgery. Aneurysm rupture occurs when the
forces acting on the aneurysm wall (stress) surpass aneurysm wall strength.
Information on both wall stress and strength might therefore improve patient
selection for prophylactic repair and reduce aneurysm related mortality.
Although aneurysm wall stress calculations are possible, no in vivo method
exists to determine aneurysm wall strength.
Study objective
To identify possible in vivo biochemical and biological markers related to
aneurysm wall strength.
Study design
Prospective, non-randomized multicentre clinical study.
Study burden and risks
Blood and urine samples will be collected both before and after aneurysm
repair. A subset of 10 Patients, enrolled at the Radboud University Nijmegen or
the Catharina Hospital Eindhoven, will be invited for preoperative MR imaging
using intravenous USPIO. Although USPIO is a non registered contrast for MR
imaging, USPIO enhanced MR is regarded safe and well tolerated. Since USPIO has
to administered 24-hours before MR imaging enrolled patients will have to visit
the outpatient clincic the day before MR imaging and hospital admission.
Aneurysm wall specimens will be collected at the time of surgery. Resection of
these excess wall specimens is safe as only a limited part of the original
aneurysm wall is needed to cover the vascular prosthesis.
Geert Grooteplein 10
6500 HB Nijmegen
Nederland
Geert Grooteplein 10
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
1. patients scheduled for conventional repair of an asymptomatic or symptomatic (non-ruptured) aneurysm.
2. Informed consent
3. Preoperative CT (computer tomography)
Exclusion criteria
1. Patients with a ruptured abdominal aortic aneurysm
2. Contraindication for MR imaging (metallic implants, claustrophobia).
3. Prior aortic surgery
4. Severe cardiac comorbidity (congestic heart failure/coronary artery disease)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-000214-37-NL |
| CCMO | NL15960.091.07 |