The primary objective will be to assess whether cerebrovascular reactivity is impaired in patients with steno-occlusive disease of the vertebrobasilar artery .
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
The primary outcome is CVR measured with MR imaging at 3 Tesla using
administration of vasodilatory challenge medication to induce hemodynamic
stress.
Secondary outcome
Secondary outcomes include cerebral blood flow (CBF) and CVR measured in the
visual cortex, and differences in CBF and CVR between the recently symptomatic
and asymptomatic patients.
Background summary
In patients with ischaemic stroke and steno-occlusive disease of the
vertebrobasilar artery it is difficult to assess which patients are at risk for
future stroke and should be treated with an endovascular or surgical procedure.
An important parameter that can predict such events is the cerebrovascular
reactivity, the vasodilatory response of the cerebral resistance vessels. The
global increase of cerebral blood flow under conditions of hemodynamic stress
is a measure of the cerebrovascular reactivity.
Study objective
The primary objective will be to assess whether cerebrovascular reactivity is
impaired in patients with steno-occlusive disease of the vertebrobasilar artery
.
Study design
This is a single centre cross-sectional study at the UMC Utrecht, comparing
asymptomatic patients and recently symptomatic patients with steno-occlusive
vertebrobasilar artery disease.
Study burden and risks
Risks of participation are associated with undergoing an MRI examination and
administration of vasodilatory challenge medication. Both associated risks are
well investigated and can be minimized according to our exclusion criteria.
Patients do not benefit individually. However results of this investigation may
prove to be valuable in understanding risk of reoccurrence of stroke in
patients with and without steno-occlusive vertebrobasilar artery disease.
Postbus 85500
3508GA Utrecht
NL
Postbus 85500
3508GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
18 years or older.
Patients with ischaemic stroke or TIA in the perfusion territory of the vertebo-basilar arteries.
In case of stroke: a clinically stable situation.
Exclusion criteria
Significant and symptomatic stenosis of the carotid arteries.
Pregnancy or possible pregnancy.
Implanted stent(s).
Severe liver or renal dysfunction.
Addison*s disease.
Allergic reaction for sulfonamides.
Cor pulmonale / heart failure (class III-IV) according to the NYHA classification.
Longobstruction / emfysema.
Primary hyperaldosteronisme.
Fenytoïne, primidon and/or fenobarbital use.
Japanese and Indian subjects or subjects of Japanese descent.
Impossibility to undergo MRI (claustrophobia, metal objects in or around the body).
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2010-022875-70-NL |
| CCMO | NL33961.041.10 |