Observing inflammation's impact on small vessel disease and cognitive decline
INflammation and Small Vessel Disease Study
This study is trying to see how inflammation affects brain health and thinking skills in people with small vessel disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Cambridge Academic / other |
| Locations | 2 sites (Nijmegen and 1 other locations) |
| Trial ID | NCT05746221 on ClinicalTrials.gov |
What this trial studies
This observational cohort study investigates the relationship between systemic inflammation and brain white matter damage in patients with cerebral small vessel disease. Conducted at the University of Cambridge and Radboud University Medical Centre, the study aims to recruit 200 participants, with 100 from each site. Participants will undergo MRI scans to assess brain changes and cognitive function over time. The study is funded by a joint grant from the British Heart Foundation and Dutch Heart Foundation.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and over with symptomatic cerebral small vessel disease, including those with lacunar stroke syndrome or cognitive impairment.
Not a fit: Patients with contraindications for MRI or those with stroke causes other than small vessel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cerebral small vessel disease and its associated cognitive decline.
How similar studies have performed: While the specific approach of this study is observational, similar studies have shown promising results in understanding the links between inflammation and cerebrovascular diseases.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Nijmegen and 1 other locations
- Radboud University Medical Centre — Nijmegen, Netherlands (Recruiting)
- University of Cambridge — Cambridge, Cambridgeshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Hugh S Markus — University of Cambridge
- Study coordinator: Hugh S Markus
- Email: hsm32@medschl.cam.ac.uk
- Phone: +44 (0)1223 856661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.