Aim of the study is to study systemic microvascular changes in patients with cerebral small vessel disease compared with patients with large vessel atherosclerosis.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the difference in endothelial microvascular
glycocalyx thickness between patients with cerebral small vessel disease and
patients with large vessel atherosclerosis.
Secondary outcome
The presence of blood parameters related to glycocalyx destruction in patients
with cerebral small vessel disease.
The presence of microalbuminuria in both research groups.
The presence of pathological changes in microvessels found in skin biopsy.
Background summary
Cerebral small vessel disease (CSVD) causes about 30% of all ischemic strokes,
but little is known about its pathophysiology. In contrast to large vessel
atherosclerosis there is far less known about the best prevention and therapy
of CSVD. We hypothesize that CSVD is a generalized vascular disorder, and is
associated with destruction of the endothelial glycocalyx.
Study objective
Aim of the study is to study systemic microvascular changes in patients with
cerebral small vessel disease compared with patients with large vessel
atherosclerosis.
Study design
Pilot study
Study burden and risks
The patients will be asked to visit the hospital once, for the following
investigations: venous blood sample, a urine sample, and a punch biopsy of the
skin to determine the quality of the microvasculature. The endothelial
glycocalyx will be imaged by orthogonal polarisation spectral imaging and
retinal angiography. All investigational techniques are nearly without any risk
or side effect. The total time of one visit will be approximately 2-3 hours.
Postbus 22660
1100 DD Amsterdam
Nederland
Postbus 22660
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria cerebral large vessel disease group
TIA or stroke patients with one of the following:
-clinically demonstrated loss of sensibility
-clinically demonstrated loss of motor function;and including one or more of the following:
-hemianopsia
-aphasia
-neglect;and a carotid stenosis of more than 70% at the ipsilateral side.
Inclusion criteria cerebral small vessel disease group
Patients with a clinically established lacunar syndrome (see appendix A) and lacunar infarcts and/or leukoaraiosis on CT.
Exclusion criteria
Exclusion criteria for both groups are:
-Age of less than 18 years
-Incapacitated subjects
-A Modified Rankin Scale (MRS) >3
-Diabetes Mellitus type I and II
-Smoking
-Iodine allergy
-Hyperthyroidism
Exclusion criteria cerebral large vessel disease group
-Lacunar infarcts and/or leukoaraiosis on CT
-Indication of a cardiac source of intracranial embolism;Exclusion criteria cerebral small vessel disease group
-Carotid stenosis of more than 30%
-Intermittent claudication
-Angina pectoris
-Myocardial infarction
-Radiologically demonstrated cortical infarction
Design
Recruitment
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 |
|---|---|
| CCMO | NL17848.018.07 |