Carotid occlusive disease
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a patient must meet all of the following criteria: - At least 55 years of age; - Occlusion of the internal carotid artery (ICA) as visible on MR or CT angiography, or DSA; - Mini-mental state examination (MMSE) is higher or equal to 18; - Patients must, in the opinion of the principal investigator/attending neurologist, be able to tolerate the [18F]Florbetaben PET scan procedures and be competent to make a well in-formed decision to participate in this study;
Exclusion criteria
Exclusion criteria: A potential patient who meets any of the following criteria will be excluded from participation in this study: - Contralateral stenosis of >70% of the ICA or middle cerebral artery (MCA); - History of vascular reconstructive surgery in the brain; - Has evidence of structural abnormalities such as mass on MRI that is likely to interfere with the clinical presentation and/or interpretation of PET scan; - Has ever participated in an experimental study with an amyloid targeting agent, unless it can be documented that the subject received only placebo during the course of the trial; - Has been injected with a previously administered radiopharmaceutical within 6 months terminal half-lives OR when the total yearly radiation exposure exceeds 10 mSv; - Has other neurological diagnosis, such as Parkinson*s disease, multiple sclerosis or severe traumatic brain injury, or a major psychiatric disorder;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main endpoint is the difference in [18F]Florbetaben binding potential (BPnd) between the affected hemisphere and the contralateral hemisphere. Second endpoint is the difference in perfusion between hemispheres, using the parametric images of relative trace flow (R1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcome measures are the relationship between amyloid-β deposition and relative perfusion (R1), the relationship between amyloid-β deposition and relative perfusion to cognitive functioning and the relationship between amyloid-β deposition and relative perfusion to structural neuroimaging parameters (i.e. vascular brain injury and atrophy) in patients with COD. | — |
Countries
Netherlands
Outcome results
None listed