Recruiting NCT05734378
Prognosis of Cerebral Small Vessel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cerebral Amyloid Angiopathy, Small Vessel Cerebrovascular Disease, Cadasil, CAA - Cerebral Amyloid Angiopathy. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prognosis of Cerebral Small Vessel Disease - a Prospective Cohort Study (PRO-SVD)
Overview
Prognosis of small vessel disease (SVD) depends on the underlying type of SVD and index manifestation. The aim of this prospective, observational cohort study is to determine the risk of different outcome events among patients with SVD according to the type of index presentation.
Primary outcome measures
- Intracerebral haemorrhage (ICH) [Time frame: 1 year]
- Ischaemic stroke [Time frame: 1 year]
- Cardio-vascular death [Time frame: 1 year]
Secondary outcome measures (5)
- Other intracranial bleeding [Time frame: 1 year]
- Other (transient) neurological attacks [Time frame: 1 year]
- Cognitive impairment [Time frame: 1 year]
- New-onset of extracranial vascular disease [Time frame: 1 year]
- Functional outcome [Time frame: 1 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Department of Neurology, Inselspital Bern University Hospital — Bern
Identifiers
NCT: NCT05734378 · 2020-02535