1. To assess the prevalence of gadolinium-enhancement of the aneurysm wall in patients with unruptured aneurysms2. To assess the relation between gadolinium-enhancement of the aneurysm wall and a. The use of anti-inflammatory drugs (including…
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The presence (present/absent) of gadolinium-enhancement of the aneurysm wall on
3 Tesla MR-angiography (MRA).
If evaluation of the first 15 patients results in the possibility of a
semi-quantitative outcome endpoint for contrast enhancement
(none/mild/severe/complete), we will discuss the use of this endpoint with the
entire study group.
Secondary outcome
Determinants of gadolinium-enhancement:
a. The use of anti-inflammatory drugs (including acetylsalicylic acid);
b. Hypertension;
c. The size of the aneurysm;
d. The relation with smoking.
Background summary
Rupture of an intracranial aneurysm results in aneurysmal subarachnoid
hemorrhage (SAH). Currently, unruptured aneurysms can be treated with surgical
clipping or endovascular coiling to prevent SAH, but both treatments carry a
5-15% risk of unfavorable outcome. Therefore, patients and their treating
physicians have to weigh the balance between the risk of rupture and the risk
of treatment complications. In general, small aneurysms with a low risk of
rupture are left untreated. However, most episodes of SAH come from small
aneurysms, because small aneurysms are much more prevalent. Thus, additional
treatment strategies with a low risk of complications are needed that can be
used in patients with aneurysms with a low risk of rupture. A growing body of
evidence suggests that aneurysm wall inflammation contributes to aneurysm
growth and rupture. In patients with other vasculopathies such as intracranial
atherosclerosis and vasculitis, 3 Tesla MRI vessel wall imaging can be used to
detect sites with inflammation. Detection of aneurysm wall inflammation in-vivo
would pave the way for a randomized controlled trial to investigate the effect
of anti-inflammatory drugs on aneurysm growth and rupture. In this study, we
will investigate the prevalence of gadolinium-enhancement of the aneurysm wall
and its determinants (use of anti-inflammatory drugs, hypertension, aneurysm
size and smoking behaviour) in patients with unruptured intracranial aneurysms.
The overall aim of the proposed study is to develop a new, non-invasive medical
treatment strategy that reduces the risk of rupture for patients with
unruptured intracranial aneurysms. In the present study we will assess the
prevalence of inflammation of the aneurysm wall and its determinants in
patients with unruptured intracranial aneurysms.
Study objective
1. To assess the prevalence of gadolinium-enhancement of the aneurysm wall in
patients with unruptured aneurysms
2. To assess the relation between gadolinium-enhancement of the aneurysm wall
and
a. The use of anti-inflammatory drugs (including acetylsalicylic acid);
b. Hypertension;
c. The size of the aneurysm;
d. The relation with smoking.
Study design
The proposed study is a single-center, cross-sectional study.
Study burden and risks
The extent of burden and risks for participants of this study are minimal. The
patients included in the proposed study regularly undergo 3 Tesla MRA or CTA as
part of the clinical care for evaluation of possible growth of their unruptured
aneurysm. For patients that are scheduled for MRA, the proposed study adds
administration of gadolinium to the MRA-protocol for additional aneurysm wall
imaging, which results in prolongation of the scan time of approximately 20
minutes. For patients that are scheduled for CTA, the proposed study adds an
additional MRI with MRA and aneurysm wall imaging (scan duration of
approximately 25 minutes). For patients that are not scheduled for MRI/CTA
(thus patients that are asked to visit the hospital for a study visit),
participation in the proposed study will include an MRI with MRA and aneurysm
wall imaging (scan duration of approximately 25 minutes). In addition, included
patients have to complete a questionnaire on risk factors for aneurysm rupture
and their use of medication, which will take approximately 30 minutes.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
18 years or older.
Patient is diagnosed with one or more unruptured intracranial aneurysms confirmed on digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA).
Informed consent signed by subject.
Exclusion criteria
Medical history of sever renal insufficiency: GFR<30ml/min/1.73m; nephrogenic systemic fibrosis / nephrogenic fibrosing nephropathy (NSF/NFD).
Gadolinium contrast allergy.
Pregnancy.
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 | NL48746.041.14 |