To determine whether it is possible to identify adventitial fattening of the aortic wall in patients with an abdominal aortic aneurysm using MRI techniques and use this adventitial fattening as a new biomarker for AAA patients.
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
adventitial fattening of the aortic wall.
Secondary outcome
The morphological description of the plaque, the number and size of the vaso
vasora, the measurements of vascular wall stress, the pulse wave velocity
measurements.
Aneurysm diameter, aneurysm related complaints, the serum markers of
inflammation.
Age, length, height, gender, body weight, smoking, diabetes mellitus,
cardiovascular risk pattern, family history of aneurysm presence, additional
relevant medical history.
Background summary
We found that fat degeneration of the adventitial layer of the aortic wall is
the main cause of rupture in AAAs. Therefore, the purpose of the present study
is to evaluate adventitial fattening of the aortic wall in patients with an
abdominal aortic aneurysm to provide a new tool for risk stratification in
these patients.
Study objective
To determine whether it is possible to identify adventitial fattening of the
aortic wall in patients with an abdominal aortic aneurysm using MRI techniques
and use this adventitial fattening as a new biomarker for AAA patients.
Study design
First: Pilot study, Second: Pilot study and Third: a cross sectional study.
Study burden and risks
Currently the main criterion for abdominal aortic aneurysm (AAA) repair is an
aneurysm diameter of >=5.5 cm. However, some AAA*s rupture when they are
smaller, whereas other aneurysms are discovered when they have exceeded this
critical diameter but have not ruptured. Amongst others, therefore it seems
that size alone has a suboptimal sensitivity and specificity, causing costly
unnecessary treatments or unexpected rupture. Therefore, a more sensitive and
specific marker is wanted for the treatment of individual AAA patients.
Within this study the MRI scanner is used to determine if the adventitial
fattening of the aneurysm wall can provide better risk stratification for these
patients. The advantage of the MRI scanner is that it is believed to be
harmless to the patient. The burden for the patients will be the gadolinium
contrast during the MRI scan, the one vena punction, the time they spend
filling out the questionnaire and the MRI scanning time. The questionnaire will
be completed when the patients give their informed consent and the scanning &
vena punction will take place the same day. There is no need for a second
visit.
Albinusdreef 2
2300 RC Leiden
NL
Albinusdreef 2
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Volunteers: >= 18 years
Patients: >= 40 years, aneurysm patients (aneurysm is detected with ultrasound)
Exclusion criteria
A known gadolinium allergy, kidney dysfunction with a GFR <30 and patients with implants and (ferromagnetic) foreign bodies (pacemakers, vagus nerve stimulators, ICDs, loop recorders, insulin pumps, cochlear implants, deep brain stimulators, metal sliver in the eye, an intra-uterine device), claustrophobia , (possible) pregnancy before 12 weeks.
Design
Recruitment
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 |
|---|---|
| CCMO | NL33854.058.10 |