We hypothesize that intracranial vessel wall atheromas are an important underlying cause of middle cerebral artery obstruction. To test our hypothesis we will perform high resolution intracranial vessel wall imaging with a 7.0 Tesla MRI scanner in…
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
Secondary study parameters are signal characteristics of the intracranial
vessel wall atheroma on multiple MRI-sequences and two different magnetic field
strengths, combined with histology as golden standard if applicable. Our
(secondary) outcome will be cognitive functioning of the subject, in
association with possible microvascular damage.
Background summary
Atherosclerosis of the intracranial arteries has been shown to be correlated
with a high recurrent stroke risk. Especially, patients with a hyperdense
vessel sign on CT are known to have a very poor prognosis with a high morbidity
and mortality. Microvascular damage (microbleeds, microinfarcts) could also
play a role in this context, which is associated with cognitive decline. To the
best of our knowledge no previous research has been performed to characterize
the intracranial arterial vessel wall, or to investigate a possible correlation
between vessel wall abnormalities, microvascular damage and cognitive
funtioning.
Study objective
We hypothesize that intracranial vessel wall atheromas are an important
underlying cause of middle cerebral artery obstruction. To test our hypothesis
we will perform high resolution intracranial vessel wall imaging with a 7.0
Tesla MRI scanner in stroke patients, TIA patients and controls. As secondary
objectives we will characterize the intracranial vessel wall atheroma with
correlation to histology, and we will compare intracranial vessel wall imaging
with 7.0 Tesla and 3.0 Tesla. We will also investigate microvascular damage and
cognitive functioning. 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. Also, a statement can be
made regarding a possible correlation between microvascular damage, cognitive
functioning and intracranial atherosclerosis.
Study design
For collection of data, all stroke patients and TIA patients will undergo a
first 7.0 Tesla MRI scan within 1 week after initial ischemic symptoms; a
second 7.0 Tesla MRI scan will be performed 1 month after initial ischemic
symptoms. A subgroup of 20 TIA patients will undergo an MRI scan in a 3.0 Tesla
MRI scanner, in addition to the two 7.0 Tesla MRI-scans, for comparison with
7.0 Tesla results. Healthy controls will undergo a 3.0 Tesla and 7.0 Tesla MRI
scan. Histology samples will be scanned with 3.0 and 7.0 Tesla MRI. All
subjects will also undergo neuropsychological tests.
Study burden and risks
Stroke- and TIA patients will undergo a first 7.0 Tesla MRI scan within 1 week
after onset of ischemic symptoms; the second 7.0 Tesla MRI scan will be
performed 1 month later. A subgroup of TIA patients will undergo a 3.0 Tesla
MRI scan in addition to the 7.0 Tesla MRI-scans, which will be planned if
possible in combination with the second MRI scan to prevent frequent visits to
the UMCU. This also applies to the controls, who will be scanned with both 3.0
and 7.0 Tesla MRI scanner. During one of the visits neuropsychological tests
will also be performed. Subjects will be screened for contraindications for MRI
and contrast agent, to reduce possible risks to a minimum.
Schelpstraat 20
3581 VR Utrecht
Nederland
Schelpstraat 20
3581 VR Utrecht
Nederland
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 1 week after onset of ischemic symptoms;Additional inclusion criteria for stroke patients:
• Ischemic symptoms conform PACI/TACI (Partial/Total Anterior Circulation Infarct)
• CT acute stroke imaging protocol: area of ischemia of the cerebral anterior perfusion territory based either on anatomical CT images or on CT perfusion images;Additional inclusion criteria for TIA patients:
• Transient ischemic symptoms (< 24 hours of duration) conform PACS/TACS (Partial/Total Anterior Circulation Syndrome)
• No area of ischemia visualized on either anatomical CT images or on CT perfusion images
Exclusion criteria
• Stroke patients with either a hyperdense vessel sign on CT or occlusion of an artery of the anterior cerebral circulation on CT angiography, but not both or neither
• Patients with a known cardiac cause of stroke
• Patients with a stroke secondary to surgical / interventional procedures
• Allergic reaction to gadolinium
• Impossibility to undergo MRI (claustrophobia, implants or metal objects in or around the body)
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 | NL27873.041.09 |