MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events - a Prospective Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracerebral Hemorrhage
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Disease progression
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a nested cohort study in the PRO-SVD cohort. Small vessel disease is a chronic disease and is thought to progress over time. MRI is the gold standard to diagnose small vessel disease, but data on MRI-visible disease progression are scarce. Complications of small vessel disease as well as location pattern, distribution and severity of these MRI small vessel disease markers differ according to the underlying phenotype. The primary aim of this project is to investigate individual small vessel disease burden progression detected by MRI in survivors or intracerebral hemorrhage.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient participating in the PRO-SVD cohort
- •Symptomatic intracranial hemorrhage
- •Written informed consent provided by patient or next-of-kin
- •No contraindications against MRI
Exclusion Criteria
- •Patient unsuitable for MRI follow-ups (e.g. claustrophobia)
- •Patients unlikely to attend 1-year follow-up
- •For healthy controls
- •Inclusion Criteria:
- •Clinically healthy person ≥ 55 years
- •Written informed consent provided by the healthy control
- •No contraindications against MRI
- •Exclusion Criteria:
- •Known or suspected cerebral small vessel diseases or presence of concurrent diseases potentially mimicking small vessel disease (e.g. multiple sclerosis, previous heart surgery etc.)
- •Pre-existing dementia, cognitive decline or disorder of the central nervous system.
Outcomes
Primary Outcomes
Disease progression
Time Frame: 24 months
Composite endpoint of a new, clinically symptomatic ischaemic or haemorrhagic event as defined by the treating physician and/or any increase in small vessel disease and/or cerebral amyloid angiopathy burden according to small vessel disease burden score (range 0-4 points, higher score means higher small vessel disease burden) or cerebral amyloid angiopathy burden score (range 0-6 points, higher score means higher cerebral amyloid angiopathy burden), respectively.
Secondary Outcomes
- MRI-defined disease progression(24 months)
- Increase in perivascular space severity scale(24 months)
- Increase in number of SVD-attributable, ischaemic lesions(24 months)
- Functional outcome(24 months)
- New cognitive impairment(24 months)
- Increase in number of SVD-attributable, haemorrhagic lesions(24 months)
- Clinical, vascular outcome event(24 months)