We hypothesize that intracranial vessel wall atheromas are an important underlying cause of obstruction of (one of the) artery(ies) of the anterior cerebral circulation. To test our hypothesis we will perform high resolution intracranial vessel wall…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our main study parameter is the presence or absence of intracranial
atherosclerosis in one (or more) arteries of the anterior cerebral circulation
in the aforementioned groups.
Secondary outcome
Our secondary study parameters are signal characteristics of the intracranial
vessel wall atheroma, specifically unstable atheroma, on multiple MRI
sequences, and assessment of clinical consequences of intracranial
atherosclerosis by evaluation of standard brain imaging.
Furthermore we would like to evaluate the accuracy and utility of the short
vessel wall sequence compared to the current more time-consuming vessel wall
sequence. We will assess whether this short vessel wall sequence has the
potential to replace the longer vessel wall sequence in future.
Background summary
Atherosclerosis of the intracranial arteries has been shown to be correlated
with a high recurrent stroke risk. To the best of our knowledge, no previous
research has been performed to characterize the intracranial arterial vessel
wall.
Study objective
We hypothesize that intracranial vessel wall atheromas are an important
underlying cause of obstruction of (one of the) artery(ies) of the anterior
cerebral circulation. To test our hypothesis we will perform high resolution
intracranial vessel wall imaging with a 7.0 Tesla and 3.0 Tesla MRI scanner in
stroke patients and TIA patients. To obtain a basic understanding of the
possible clinical and subclinical consequences of these intracranial vessel
wall atheroma, we will also image the whole brain. With these data we will not
only be able to visualise the intracranial arterial vessel wall to obtain
information on presence of atherosclerosis, but we could also ultimately
provide valuable information regarding possible presence of an instable
atheroma, by describing signal characteristics of these atheroma, and provide a
basic understanding of the possible consequences of atherosclerosis of
intracranial arteries.
Study design
For collection of data, all stroke patients and TIA patients will undergo a 7.0
Tesla MRI scan within 3 months after initial ischemic symptoms, together with
collection of baseline characteristics. A 3.0 Tesla MRI scan will be also
performed within 3 months.
Study burden and risks
Patients receive 2 MRI scans, the first one within one month after onset of
symptoms, the second one within 3 months after the first scan. Baseline
characteristics of all subjects will be collected, and all patients will
undergo one session. To reduce possible risks to a minimum, subjects will be
screened for contraindications for MRI and contrast agent.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Main inclusion criteria for stroke patients and TIA patients:
• 18 years or older
• Male or female
• Ready for MRI scanning within 3 months after onset of ischemic symptoms;Additional inclusion criteria for stroke patients:
• Ischemic symptoms conform PACI/TACI (Partial/Total Anterior Circulation Infarct);Additional inclusion criteria for TIA patients:
• Transient ischemic symptoms (< 24 hours of duration) conform PACS/TACS/LACS (Partial/Total/Lacunar Anterior Circulation Syndrome)
Exclusion criteria
• Patients with a stroke secondary to surgical / interventional procedures
• Allergic reaction to gadolinium
• Patients with impaired renal function (severe renal insufficiency, GFR < 30ml/min/1,73m2; or nephrogenic systemic fibrosis / nephrogenic fibrosing nephropathy (NSF/NFD))
• Impossibility to undergo MRI (claustrophobia, implants or metal objects in or around the body)
• Patients who cannot be scanned <3 months.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL28606.041.09 |
| Other | NTR2119 (www.trialregister.nl) |
| OMON | NL-OMON22252 |