The main goal of this pilot study is to analyze if using the 7.0 Tesla MRI scanner potential markers predicting aneurysmal rupture (i.e thickness and enhancement of the aneurysmal wall) can be studied in IA patients.
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To study whether the thickness and enhancement of the aneurysmal wall can be
studied in patients with unruptured IA using 7.0 Tesla MRI.
Secondary outcome
Secondary objective: to optimize the scanning protocol for visualization of
enhancement of aneurysmal wall
Tertiary objective: To study whether differences in the thickness and
enhancement of the aneurysmal wall exists between small unruptured aneurysms of
<= 7mm and large unruptured aneurysms >7mm in size.
Background summary
Most intracranial aneurysms are discovered after rupture. Rupture results in
subarachnoid hemorrhage (SAH), which has a case fatality rate of 35%. With
greater availability and higher accuracy of the imaging techniques, unruptured
intracranial aneurysms(IA) are increasingly being discovered. These aneurysms
may give rise to SAH in the near or distant future, but our abilities to
predict which IA are going to rupture and when are limited. It is not rational
to treat all IA, because treatment carries a risk of around 5% of complications
leading to death or dependence on help for activities of daily living. Thus for
a tailored approach markers predicting rupture in individual patients are
urgently needed.
The thickness and enhancement of the aneurysmal wall may be related to a higher
risk of rupture. Size is the most important known risk factor of rupture, but
the conventional imaging can only visualize the vessel lumen which may lead to
an underestimation of size. With the new technique of high-resolution 7.0 Tesla
Magnetic Resonance Imaging (MRI) scanner the circle of Willis can be studied in
more detail.
Study objective
The main goal of this pilot study is to analyze if using the 7.0 Tesla MRI
scanner potential markers predicting aneurysmal rupture (i.e thickness and
enhancement of the aneurysmal wall) can be studied in IA patients.
Study design
This is an observational study.
Study burden and risks
This study will not have a direct benefit for the patients, but by
participating in the study the patients will make an important contribution to
the research on the cause of IA and on the cause of bleeding from such IA.
Patients with contra indications for the 7.0 Tesla MRI will be excluded for
this study. As known thus far there are no important side effects for the 7.0
Tesla MRI in patients without contra indications. The studies using 7.0 Tesla
MRI performed thus far did not give any reason for concerns on the safety of
this imaging technique. However, some patients experienced complaints of
nausea and dizziness when walking too fast through the magnetic field. These
complaints are temporarily and are not considered to be harmful. When the
patients move slowly through the room with the scanner and when they are moved
slowly into the scanner the chance that the patients experience these
complaints will be diminished.
During scanning, they can experience light flashes or tingling. These
experiences will disappear immediately after completion of the scan. The risks
attributable to gadolinium are negligible since patients are excluded when they
have previously experienced an allergic reaction to gadolinium or have a
medical history of impaired renal function. Furthermore, an intravenous line
will be placed to make administration of gadolinium during the scan possible.
This might in certain cases result in minor pain, redness and swelling at the
place of injection / place of the intravenous line.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Patients of age 18 years or older capable of giving consent with an unruptured intracranial aneurysm who either need surgical clipping or endovascular treatment to treat the aneurysm or are followed through the outpatient department with routine follow-up imaging. Patients are available for scanning before possible treatment takes place.
Exclusion criteria
Patients with an unruptured intracranial aneurysm who:
• are aged 18 years or younger
• are mentally or physically incapable of giving consent
• can not undergo MRI (claustrophobia, implants or metal objects in or around the body that can influence the scanning or can compromise the safety of the patient)
• have presence of a clip on or coils in another aneurysm
• have a fusiform, mycotic or traumatic unruptured aneurysm.
• are not able to understand Dutch or English written and/or spoken patient information
•Medical history of allergic reaction to gadolinium
•Patients with a medical history of impaired renal function (severe renal insufficiency, glomerular filtration rate (GFR) < 30 ml/min/1,73 m2; or nephrogenic systemic fibrosis/ nephrogenic fibrosing nephropathy (NSF/NFD)).
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 | NL35277.041.11 |