NCT05746221 INflammation and Small Vessel Disease Study
| NCT ID | NCT05746221 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cambridge |
| Condition | Cerebral Small Vessel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-08-10 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-08-10 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Hugh S Markus
PRINCIPAL INVESTIGATOR
University of Cambridge
Frequently Asked Questions
Who can join the NCT05746221 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Cerebral Small Vessel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05746221 currently recruiting?
Yes, NCT05746221 is actively recruiting participants. Contact the research team at hsm32@medschl.cam.ac.uk for enrollment information.
Where is the NCT05746221 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Cambridge, United Kingdom.
Who is sponsoring the NCT05746221 clinical trial?
NCT05746221 is sponsored by University of Cambridge. The principal investigator is Hugh S Markus at University of Cambridge. The trial plans to enroll 200 participants.