|- candidate number||23664|
|- NTR Number||NTR5688|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-jan-2016|
|- Secondary IDs||NL43704.041.13 Institutional Review Board University Medical Center Utrecht|
|- Public Title||MRI measurements of the brain vessel walls in patients with TIA or ischemic stroke of the posterior circulation.|
|- Scientific Title||Intracranial vessel wall MR imaging at 3.0 and 7.0 tesla in patients with TIA or ischemic stroke of the posterior circulation.|
|- ACRONYM||PIVI study|
|- hypothesis||Intracranial atherosclerosis is an important cause of ischemic stroke and transient ischemic attack (TIA). Ischemic stroke or TIA in the posterior circulation accounts for approximately 20 to 30% of all ischemic events. We hypothesize that arterial vessel wall abnormalities are also common in the posterior circulation, and are an important underlying cause of obstruction of arteries in the intracranial posterior circulation and subsequent ischemic stroke. Ultimately, for wide clinical application of intracranial vessel wall imaging, a translation has to be made to lower field strength MR scanners (3.0 tesla).
The primary objective of the current study is to compare the presence or absence of arterial vessel wall abnormalities in the intracranial posterior circulation in patients with TIA or ischemic stroke with those of healthy controls using 7.0 tesla MRI. The secondary objective is to assess the sensitivity of 3.0 tesla MRI to detect the vessel wall abnormalities visualised with 7.0 tesla MRI.
|- Healt Condition(s) or Problem(s) studied||Atherosclerosis , TIA, MRI, Ischemic stroke|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following criteria:|
1. ¡Ý 18 years of age.
Additional inclusion criteria for ischemic stroke / TIA patients:
1. TIA or ischemic stroke in the posterior circulation territory (= supplied via the vertebral and basilar arteries or their branches);
2. Possibility to perform MRI scanning within 3 months after onset of relevant ischemic symptoms.
|- Exclusion criteria||A potential subject who meets any of the following criteria will be excluded from participation in this study:|
1. Allergic reaction to gadolinium or one of the constituents of its solution for administration;
2. Impossibility to undergo MRI (claustrophobia, implants or metal objects in or around the body);
3. Severely impaired renal function (severe renal insufficiency, GFR <30mL/min/1.73m2; or nephrogenic systemic fibrosis / nephrogenic fibrosing nephropathy (NSF/NFD));
Additional exclusion criteria for ischemic stroke / TIA patients:
1. A TIA or ischemic stroke secondary to a surgical or interventional procedure;
2. Previous vertebrobasilar surgery or endovascular therapy.
Additional exclusion criteria for healthy volunteers:
1. History of cerebral events (e.g. ischemic stroke, TIA, hemorrhage).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||9-jul-2013|
|- planned closingdate||1-okt-2019|
|- Target number of participants||100|
|- Primary outcome||The presence or absence of intracranial vessel wall abnormalities in arteries of the intracranial posterior circulation. Presence of atherosclerosis is defined as any irregularity of the arterial vessel wall.|
|- Secondary outcome||1. Number of vessel wall abnormalities in the intracranial vessel wall MRI scan at 7.0 tesla as compared to 3.0 tesla.
2. Characteristics of intracranial vessel wall atheroma, by discriminating different MRI signal intensities in the vessel wall atheroma.
3. The clinical outcome measures (e.g. occurrence of vascular events, level of handicap, current medication) collected during follow-up.
|- Timepoints||All participating subjects will undergo two MRI examinations, one on the 3.0 tesla MRI scanner, and one on the 7.0 tesla MRI scanner. In patients, both MRI examinations will be performed as soon as possible, but at the latest within 3 months, after symptom onset. A minimum of 12 hours is taken in between both examinations, to make sure the contrast agent has washed out sufficiently.
For measurement of clinical outcome after ischemic stroke or TIA a follow-up survey will be conducted at 3 months and at 1, 2 and 3 year(s) after inclusion in this study.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Arjen Lindenholz|
|- CONTACT for SCIENTIFIC QUERIES|| Arjen Lindenholz|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, European Research Council (ERC)|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||27-jan-2016 - 12-okt-2016|