INflammation and Small Vessel Disease Study

Launched by UNIVERSITY OF CAMBRIDGE · Feb 17, 2023

Keywords

ClinConnect Summary

The INflammation and Small Vessel Disease Study is a research trial aimed at understanding how inflammation in the body might affect brain health, specifically in people with cerebral small vessel disease. This condition can lead to problems like strokes and cognitive decline, which is difficulty with thinking and memory. The study will involve 200 participants, half from Cambridge in the UK and half from Nijmegen in the Netherlands. Researchers will use MRI scans to look for damage in the brain's white matter and see if there's a connection between inflammation and this damage.

To be eligible for this study, participants need to be at least 40 years old and have symptoms related to cerebral small vessel disease, such as a history of specific types of strokes or cognitive issues. Those interested will need to give their consent to participate and will be screened for certain health conditions that might prevent them from joining, like serious kidney problems or other neurological diseases. Participants can expect to undergo MRI scans and will be followed for two years to monitor their health and any changes in their cognitive abilities. This study is important because it could help us understand how to better treat or prevent brain damage related to small vessel diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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, as defined by the Standards for Reporting Vascular Changes on Neuroimaging (STRIVE) criteria
• • And/OR Symptoms of cognitive impairment due to SVD with lacunar infarct on MRI
• • And/OR Gait apraxia/motor impairment presumed due to SVD with lacunar infarct on MRI
• Exclusion Criteria:
• • Unable/unwilling to consent including lack of capacity to consent
• • Contraindications to taking part in MRI study as assessed by the local MRI safety questionnaire, e.g., pacemaker
• • Vaccination or infection with fever in preceding month
• * Any stroke cause other than SVD including:
• • Cardioembolic source
• • Carotid or vertebral stenosis \> 50% measured on NASCET (North American Symptomatic Carotid Endarterectomy Trial) criteria
• • Myocardial infarction in past year
• • Auto-immune/auto-inflammatory disease
• • Use of immunomodulating drugs
• • Estimated glomerular filtration rate (eGFR) =\<59 ml/min/1.73m2 within past 3 months for Cambridge, and eGFR =\<29 ml/min/1.73m2 within past 3 months for Nijmegen, in line with local guidelines. Estimated GFR will be calculated using the Modification of Diet in Renal Disease (MDRD) equation: 186 x (Creatinine / 88.4)-1.154 x (Age)- 0.203 x (0.742 if female) x (1.210 if black). Creatinine will be checked within 3 months of the MRI, and if this has not been done as part of clinical care it will be performed as a research procedure.
• • Another diagnosed chronic neurological condition (e.g. Alzheimer's, Parkinson's disease, motor neurone disease, multiple sclerosis).
• • Limited life expectancy due to another illness or chronic condition making the 2-year follow-up difficult (e.g. widespread malignancy).
• • Known monogenic cause of small vessel disease (e.g. CADASIL - Cerebral Autosomal Dominant Arteriopathy with Sub-cortical Infarcts and Leukoencephalopathy)