Imaging NeuroVascular, Endothelial and STructural Integrity in prepAration to TrEat Small Vessel Diseases

Completed

• Conditions: Cerebral Small vessel disease; stroke and dementia; 10007963; 10057166

• Registration Number: NL-OMON49782
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

* Symptomatic SVD defined as
- a history compatible with clinical lacunar stroke syndrome in the last 5
years with a recent small subcortical infarct visible on MRI scan or CT scan
compatible with the clinical syndrome.
-or cognitive impairment defined as visiting a memory clinic and a clinical
dementia rating score of * 0.5, and capacity to consent with confluent deep WMH
on MRI (defined on the Fazekas scale as deep WMH score * 2).
- or a diagnosis of CADASIL established by molecular genetic testing of the
NOTCH3 gene (presence of an archetypical, cysteine-affecting mutation) or the
presence of granular osmiophilic material in ultrastructural, electron
microscopy analysis of skin biopsy.
* Age 18 years or older
* Ability to undergo MRI
* Capacity to give written informed consent
* Independent in activities of daily living (Modified Rankin score <3)

Exclusion Criteria

* Inclusion criteria are not met
* Unwillingness or inability to give written consent
* Pregnant or breastfeeding women, women of childbearing age not taking
contraception.
* Contraindications to MRI: pacemaker, metallic foreign body (including
aneurysm clip in the brain), claustrophobia, pregnancy, neurostimulator,
pacemaker or other kinds of implanted devices or insulin pump.
* Contraindications to gadolinium contrast agent used for MRI
* Other major neurological or psychiatric conditions affecting the brain and
interfering with the study design (e.g. multiple sclerosis)
* In case of clinical lacunar stroke syndrome other causes of stroke such as
*50% luminal stenosis in large arteries supplying the area of ischaemia,
major-risk cardioembolic source of embolism, other specific causes of stroke
identified (e.g. arteritis, dissection, migraine/vasospasm, drug misuse)
* Other stroke risk factor requiring immediate intervention that would preclude
involvement in the study
* Renal impairment (eGFR <30 ml/min)
* Panic disorder

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* BBB integrity as assessed using DCE-MRI brain scan<br /><br><br /><br>* CVR as determined by BOLD MRI brain scan response to hypercapnic challenge<br /><br>(CO2 breathing as vasodilative stimulus)<br /><br><br /><br>* PVS score, count, and volume on structural MRI brain scan, assessed using<br /><br>validated methods</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* BP parameters (peak systolic, systolic, mean, diastolic arterial pressures,<br /><br>pulse pressures, and variability)<br /><br><br /><br>* Systemic measures of vascular stiffness (PWV)<br /><br><br /><br>* CSF pulsatility as an index of rate of passage of pulse waves through the<br /><br>brain (stiffness), measured using MRI brain scan.<br /><br><br /><br>* Structural MRI markers of SVD * WMH, PVS, lacunes, microbleeds, individually<br /><br>and by total SVD score.<br /><br><br /><br>* Circulating immune cells identified by FACS analysis</p><br>