RecruitingNCT05746221

INflammation and Small Vessel Disease Study

Sponsor

University of Cambridge

Enrollment

200 participants

Start Date

Aug 10, 2022

Study Type

OBSERVATIONAL

Conditions

Stroke Inflammation Cerebral Small Vessel Diseases

Summary

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.

Eligibility

Min Age: 40 Years

Inclusion Criteria6

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 Criteria13

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)