Primary Objective: To assess which measures of microvascular function on 7T MRI are affected in patients with symptomatic SVDs, relative to controlsSecondary Objective(s): To establish how microvascular function relates to:• parenchymal lesion…
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
Measures of microvascular function at 7T MRI:
- Difference in mean velocity and pulsatility index of perforator flow between
patients with SVDs and healthy controls.
- Difference in time course of the BOLD-fMRI signal to a visual stimulus in
different cortical layers between patients with SVDs and healthy controls.
- Difference in Cerebrovascular reactivity (CVR) to a hypercapnic stimulus
between patients with SVDs and healthy controls.
Secondary outcome
Relationship between measures of microvascular function at 7T MRI and:
- Severity (total burden) and location of conventional markers of SVD on 3T MRI
at baseline and progression of these lesions after 2 years.
- Cognitive functioning at baseline and decline in cognitive function after 2
years
- blood pressure (BP) and BP variability
Background summary
Cerebral small vessel diseases (SVDs) are a major cause of stroke and dementia,
and yet there is no targeted treatment. Progress in understanding the
mechanisms that drive SVDs and SVDs-related brain damage has been elusive,
until now. Zoom@SVDs is part of a coordinated programme to elucidate key
mechanisms common to different SVDs, and determine how these mechanisms
contribute to individual SVDs (SVDs@Target Project, funded by the European
Horizon 2020 Scheme).
Current approaches to study and diagnose SVD focus on lesion-detection with
MRI. However, SVD-lesions represent an end-stage and are insufficiently
specific to understand disease processes. It would be a major advance if SVDs
in humans could also be examined in terms of microvascular function. High field
strength imaging with 7TMRI now offers this possibility. In Zoom@SVDs we will
use 7T MRI to assess which aspects of microvascular function are affected in
patients with symptomatic SVDs and how microvascular function relates to other
markers of SVD-related brain injury and cognition.
Study objective
Primary Objective: To assess which measures of microvascular function on 7T MRI
are affected in patients with symptomatic SVDs, relative to controls
Secondary Objective(s): To establish how microvascular function relates to:
• parenchymal lesion presence (3T MRI) at baseline and lesion progression after
24 months
• cognitive function at baseline and cognitive decline after 24 months
• blood pressure (BP) and BP variability
Study design
Observational case-control study with two years follow-up
Study burden and risks
The burden associated with participation is that the subject will come to the
UMCU for two visits at baseline and one after two years. At these visits the
subjects are interviewed and undergo a short physical examination. There is a
cognitive assessment at baseline and again after 2 years, a 7T MRI scan of the
brain at baseline, and a 3T MRI scan at baseline and follow-up. Between the
first and the second baseline visit, there will be blood pressure recordings,
three times per day, for one week. There is a venipuncture at baseline.
There is no direct personal benefit for the patients or controls who
participate. The benefit of the project is that it will deliver a new
perspective on a common, but incompletely understood disease. There are no
known health risks of the proposed procedures. A venipuncture can give some
discomfort.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
participants must meet all of the following criteria:
-For the patients only: symptomatic SVD defined as history of clinical lacunar
stroke or cognitive impairment due to SVD
-age over 18
-ability to provide informed consent
Exclusion criteria
-Other major neurological or psychiatric conditions affecting the brain and
interfering with the study design (e.g. multiple sclerosis, epilepsy,
Parkinson*s disease)
-For the controls only: history of symptomatic SVD or pronounced silent SVD on
MRI
-Contraindications for MRI
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58737.041.16 |
| OMON | NL-OMON29334 |