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RECRUITINGOBSERVATIONAL

INflammation and Small Vessel Disease Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Have given written willing to sign a consent form 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 Who Should NOT Join This Trial: - 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Locations (2)

Radboud University Medical Centre
Nijmegen, Netherlands
University of Cambridge
Cambridge, Cambridgeshire, United Kingdom