|- candidate number||6757|
|- NTR Number||NTR2119|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-nov-2009|
|- Secondary IDs||NL28606.041.09 Institutional Review Board University Medical Center Utrecht|
|- Public Title||MRI measurements of the brain vessel walls in patients with an ischemic stroke or TIA.|
|- Scientific Title||MR Intracranial Vessel wall Imaging in ischemic stroke patients and TIA patients.|
|- ACRONYM||IVI study|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Atherosclerosis , Ischemic stroke, TIA, MRI, TIA|
|- 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).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||4-dec-2009|
|- planned closingdate||1-dec-2011|
|- Target number of participants||100|
|- 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.|
|- Timepoints||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.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD A.G. Kolk, van der|
|- CONTACT for SCIENTIFIC QUERIES||MD A.G. Kolk, van der|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU)|
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||25-nov-2009 - 4-dec-2009|