The objective of this study is to to develop a selective and non-selective whole brain ASL perfusion stress test and at 3.0 Tesla based on ASL flow territory measurements.
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
Regional changes in CBF (ml/min/100gr).
Secondary outcome
not applicable
Background summary
In symptomatic and asymptomatic patients with obstructive disease of the major
brain feeding arteries it is hard 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 reasonably well is the
vasomotor reactivity (VMR), the vasodilatory response of the cerebral
resistance vessels. The global increase in the cerebral blood flow (CBF) under
conditions of hemodynamic stress is a measure of the VMR. Thus far transcranial
Doppler (TCD) with flow velocity measurements in the middle cerebral artery is
the most widely used method of VMR assessment. TCD is a simple and relatively
cheap method, but has a large disadvantage that it only measures the flow
velocity changes in a single brain-feeding artery. Preferably a method should
be used in which the change in perfusion during the stress test can be measured
at the brain tissue level. This is important, since at this level the
contributions of collaterals, such as leptomeningeal vessels, are also
included. Arterial spin labeling (ASL) perfusion MRI is such a technique that
can measure regional CBF in ml/min/100gr tissue without injection of contrast,
without radiation exposure and with the possibility to assess the contribution
to the CBF of individual brain feeding arteries (selective ASL).
Study objective
The objective of this study is to to develop a selective and non-selective
whole brain ASL perfusion stress test and at 3.0 Tesla based on ASL flow
territory measurements.
Study design
This is an observational study in which regional VMR will be measured after an
acetazolamide (14mg/kg) challenge.
Intervention
All subjects will be administered a onetime dosis of 14 mg/kg acetazolamide.
Study burden and risks
Redness, swelling and pain can occur at the point of intravenous injection.
Acetazolamide is a commonly prescribed drug and broad experience has been in
obtained in the safety of the substance. The use of acetazolamide to access VMR
in a vasodilatory challenge has been described in numerous studies. Both the
method of administration and the dosis are in accordance with the regular
prescription possibilities. Based on the numerous published experiences with
acetazolamide as a challenge medication, we do not expect additional side
effects in the volunteers.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Man or female
- Patients with obstructive carotid artery disease or atherosclerosis
Exclusion criteria
- Pregnancy or possible pregnancy
- Severe liver or renal dysfunction
- Diabetes Mellitus
- Addison*s disease
- Allergic reaction for sulfonamides
- Cor pulmonale
- 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 | EUCTR2007.000316.85-NL |
| CCMO | NL16108.041.07 |