Actively Recruiting
Led by University of Cambridge · Updated on 2023-02-27
200
Participants Needed
2
Research Sites
N/A
Total Duration
U
University of Cambridge
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
Researchers are conducting a prospective observational cohort study to examine patients with cerebral small vessel disease (SVD). The study aims to find out if changes in systemic inflammation can predict damage to the brain's white matter as seen on MRI scans, as well as cognitive decline. Funded by the British Heart Foundation and Dutch Heart Foundation, the study will recruit 200 participants equally from Cambridge, UK, and Nijmegen, Netherlands. The research seeks to understand how immune system changes relate to disease progression and brain health in SVD. Participants will undergo clinical, neurological, and cardiovascular assessments, cognitive and motor testing, blood sampling for immune cell analysis, and MRI brain scans at the start of the study and again after two years. The MRI scans will be performed using identical machines at both research centers. Follow-up clinical and cognitive assessments will continue every two years for up to six years to monitor stroke and dementia development, supported by separate funding. During their involvement, participants will have blood tests, clinical exams, and brain imaging to track inflammation markers and brain white matter condition. Researchers will measure changes in immune cell function, brain white matter microstructure, cognitive performance, blood-brain barrier permeability, and other MRI markers of SVD. The study ensures participants are fully informed and consent is obtained, with ongoing monitoring to assess disease progression and cognitive decline over several years.
CONDITIONS
INflammation and Small Vessel Disease Study
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including clinical and eligibility assessments, ECG, and carotid artery duplex as applicable
Duration - 1 day
Participants undergo baseline clinical assessment, neurological and cardiovascular examination, cognitive testing, motor assessment, blood taking for immune phenotyping, and MRI brain scans to evaluate cerebral small vessel disease.
1 baseline visit (in-person) involving multiple assessments and MRI scanning
Duration - Up to 6 years
Participants are followed up every two years with clinical and cognitive assessments and MRI brain scans to monitor disease progression and cognitive decline.
Visits at 2 years and every 2 years thereafter for up to 6 years (in-person)
Total: 2 locations
1
Radboud University Medical Centre
Nijmegen, Netherlands
Actively Recruiting
2
University of Cambridge
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
H
Hugh S Markus
A
Audrey Low
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Audrey Low, Sanne van Winden, Lupei Cai...
https://pubmed.ncbi.nlm.nih.gov/38413153