MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events

Insel Gruppe AG, University Hospital Bern60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Intracerebral Hemorrhage CAA - Cerebral Amyloid Angiopathy Cerebral Small Vessel Diseases

Interventions

Combined 3- and 7 Tesla-MRI

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

For patients with intracerebral hemorrhage 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

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.

Time frame: 24 months

Secondary Outcomes

MRI-defined disease progression

Any increase in small vessel disease (SVD) and/or cerebral amyloid angiopathy (CAA) 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.

Time frame: 24 months

Increase in number of SVD-attributable, ischaemic lesions

Composite outcome defined as any increase in numeric count for lacunes and/or increase in perivascular space severity scale (0/1-10 PVS/11-20 PVS/21-40 PVS/\>40 PVS) and/or increase in periventricular or deep separate white matter Fazekas scale.

Time frame: 24 months

Increase in number of SVD-attributable, haemorrhagic lesions

Composite outcome defined as any increase in numeric count for cerebral microbleeds and/or increase in cortical superficial siderosis multifocality score.

Time frame: 24 months

Increase in perivascular space severity scale

Defined as any increase in perivascular space (PVS) severity scale (0/1-10 PVS/11-20 PVS/21-40 PVS/\>40 PVS, higher number of PVS means higher small vessel disease burden).

Time frame: 24 months

Clinical, vascular outcome event

Composite endpoint including any of the following, clinically apparent events: * ischaemic stroke as diagnosed by CT or MRI and causing a corresponding clinical deficit (as assessed by the treating physician) * intracerebral haemorrhage as diagnosed by CT or MRI and causing a corresponding clinical deficit (as assessed by the treating physician) * systemic vascular event defined as radiological or clinical evidence of arterial hypoperfusion and judged by the treating physician to be due to an atherosclerotic or embolic cause.

Time frame: 24 months

Functional outcome

Modified Rankin Scale (ordinal scale, range 0-6 with 0 corresponding to no symptoms at all and 6 corresponding to death).

Time frame: 24 months

New cognitive impairment

Montreal Cognitive Assessment (MoCA, range 0-30 points) \< 26 points (corresponding to impaired cognitive function) and/or new impairment in activities of daily living as defined by the treating physician .

Time frame: 24 months

MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts