No registrations found.
ID
Source
Brief title
Health condition
Atherosclerosis, stroke, TIA, intracranial, vessel wall, MRI, magnetic resonance imaging.
Atherosclerose, herseninfarct, cerebraal infarct, intracraniaal, TIA, vessel wall, MRI.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The presence or absence of intracranial atherosclerosis (intracranial vessel wall atheroma) in arteries of the anterior cerebral circulation in the studied groups (stroke patients and TIA patients).
Secondary outcome
Characterization of the intracranial vessel wall atheroma, specifically unstable atheroma, by MR signal on multiple MRI-sequences, and assessment of clinical consequences of intracranial atherosclerosis by evaluation of standard brain imaging and neuropsychological tests.
Background summary
Atherosclerosis of the intracranial arteries has shown to be correlated with a high recurrent stroke risk. Our primary hypothesis is that intracranial vessel wall atheromas are an important underlying cause of obstruction of arteries of the anterior cerebral circulation. To test our hypothesis we will perform high resolution intracranial vessel wall imaging with a 7.0 Tesla MRI scanner in stroke patients and TIA patients.
For this single center prospective case control study, 50 stroke patients with occlusion of an anterior cerebral circulation artery on CT angiography and 50 TIA patients, all above 18 years of age and of all gender, will be recruited from the department of neurology of the UMCU. Our main study parameter is the presence or absence of intracranial atherosclerosis in an anterior cerebral circulation artery in the aforementioned groups; our secondary study parameters are signal characteristics of the intracranial vessel wall atheroma on multiple MRI-sequences. 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 together with collection of baseline characteristics; a second 7.0 Tesla MRI scan will be performed 1 month after initial ischemic symptoms, together with one session of neuropsychological tests.
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 objective
Atherosclerosis of the intracranial arteries has shown to be correlated with a high recurrent stroke risk. Our primary hypothesis is that intracranial vessel wall atheromas are an important underlying cause of obstruction of arteries of the anterior cerebral circulation. To test our hypothesis we will perform high resolution intracranial vessel wall imaging with a 7.0 Tesla MRI scanner in stroke patients and TIA patients.
Study design
Stroke and TIA patients will undergo one 7 Tesla MRI scan approximately within 1 week after first symptoms, and a second 7 Tesla MRI scan together with neuropsychological tests 1 month after first symptoms.
Intervention
N/A
A.G. Kolk, van der
Utrecht 3508 GA
The Netherlands
+31 (0)88 7556687
A.G.vanderKolk@umcutrecht.nl
A.G. Kolk, van der
Utrecht 3508 GA
The Netherlands
+31 (0)88 7556687
A.G.vanderKolk@umcutrecht.nl
Inclusion criteria
Main inclusion criteria for stroke patients and TIA patients:
1. 18 years or older;
2. Male or female;
3. Ready for MRI scanning within 1 week after onset of ischemic symptoms.
Additional inclusion criteria for stroke patients:
1. Ischemic symptoms conform PACI/TACI (Partial/Total Anterior Circulation Infarct);
2. CT acute stroke imaging protocol: area of ischemia of the anterior cerebral circulation territory based either on anatomical CT images or on CT perfusion images & occlusion of anterior cerebral circulation artery on CT angiography.
Additional inclusion criteria for TIA patients:
1. Transient ischemic symptoms (< 24 hours of duration) conform PACS/TACS (Partial/Total Anterior Circulation Syndrome);
2. No area of ischemia visualized on either anatomical CT images or on CT perfusion images.
Exclusion criteria
Exclusion criteria:
1. Stroke patients without occlusion of an artery of the anterior cerebral circulation on CT angiography;
2. Patients with a known cardiac cause of stroke;
3. Patients with a stroke secondary to surgical / interventional procedures;
4. Allergic reaction to gadolinium;
5. Patients with impaired renal function (severe renal insufficiency, GFR < 30ml/min/1,73m2; or nephrogenic systemic fibrosis / nephrogenic fibrosing nephropathy (NSF/NFD));
6. 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
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2002 |
| NTR-old | NTR2119 |
| CCMO | NL28606.041.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON47383 |