Actively Recruiting
INflammation and Small Vessel Disease Study
Led by University of Cambridge · Updated on 2023-02-27
200
Participants Needed
2
Research Sites
207 weeks
Total Duration
On this page
Sponsors
U
University of Cambridge
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
A prospective observational cohort study in patients with cerebral small vessel disease deterring whether changes in systemic inflammation predict brain white matter damage measured using MRI and cognitive decline. This is a study funded by a joint BHF-Dutch Heart Foundation research grant and will be conducted in both Cambridge UK and Nijmegen Netherlands with 100 of the 200 total participants recruited at each site, and data from both sites analysed together.
CONDITIONS
Official Title
INflammation and Small Vessel Disease Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have given written informed consent to participate
- Be aged 40 years and over
- Have symptomatic cerebral small vessel disease (SVD) defined as clinical lacunar stroke syndrome with lacunar infarct per STRIVE criteria
- And/or symptoms of cognitive impairment due to SVD with lacunar infarct on MRI
- And/or gait apraxia or motor impairment presumed due to SVD with lacunar infarct on MRI
You will not qualify if you...
- Unable or unwilling to consent including lack of capacity to consent
- Contraindications to MRI, such as having a pacemaker
- Recent vaccination or infection with fever in the past month
- Any stroke cause other than SVD, including cardioembolic source or carotid/vertebral stenosis over 50% per NASCET criteria
- Myocardial infarction in the past year
- Autoimmune or auto-inflammatory disease
- Use of immunomodulating drugs
- Reduced kidney function with eGFR \u2264 59 ml/min/1.73m2 in Cambridge or \u2264 29 ml/min/1.73m2 in Nijmegen within past 3 months
- Another diagnosed chronic neurological condition (e.g., Alzheimer's, Parkinson's, motor neurone disease, multiple sclerosis)
- Limited life expectancy due to another illness making 2-year follow-up difficult
- Known monogenic cause of small vessel disease (e.g., CADASIL)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Radboud University Medical Centre
Nijmegen, Netherlands
Actively Recruiting
2
University of Cambridge
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
Research Team
H
Hugh S Markus
CONTACT
A
Audrey Low
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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