Understanding the prognosis of cerebral small vessel disease
Prognosis of Cerebral Small Vessel Disease - a Prospective Cohort Study (PRO-SVD)
This study looks at how different types of cerebral small vessel disease affect the health and future outcomes of patients, including issues like bleeding in the brain and memory problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT05734378 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to assess the prognosis of patients with cerebral small vessel disease (SVD) by examining the risk of various outcome events based on the type of SVD and its initial presentation. It includes patients with conditions such as hypertensive deep perforator arteriolopathy and cerebral amyloid angiopathy, focusing on symptomatic manifestations like intracerebral hemorrhage and cognitive impairment. The study will follow these patients over time to gather data on their health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with symptomatic cerebral small vessel disease, including those with hypertensive arteriopathy or cerebral amyloid angiopathy.
Not a fit: Patients with a life expectancy of less than six months due to non-SVD related causes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the prognosis of different types of cerebral small vessel disease, leading to better management strategies for affected patients.
How similar studies have performed: While there have been studies on cerebral small vessel disease, this specific approach focusing on prognosis based on index presentation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hypertensive deep perforator arteriolopathy (DPA), clinically symptomatic with either ICH, ischaemic stroke, cognitive impairment or severe radiological manifestation (Fazekas ≥II) * Cerebral amyloid angiopathy (CAA according to modified Boston or Edinburgh criteria), clinically symptomatic with either ICH (including cSAH), amyloid spells, cognitive impairment or severe radiological manifestation (CMB≥2) * Other SVD (i.e. CADASIL or other sporadic or genetic SVD) Exclusion Criteria: * Life expectancy of \<6 months due to not-SVD related causes (i.e. cancer) * Patient is unlikely to attend follow-up visits
Where this trial is running
Bern
- Department of Neurology, Inselspital Bern University Hospital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: David J Seiffge, Prof, MD — Department of Neurology, Inselspital Bern University Hospital
- Study coordinator: Marianne Kormann
- Email: studien.stroke@insel.ch
- Phone: +41 31 632 70 00
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.