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

Recruiting

• Conditions: Cerebral Small Vessel Diseases; Intracerebral Hemorrhage; CAA - Cerebral Amyloid Angiopathy
• Interventions: Diagnostic Test: Combined 3- and 7 Tesla-MRI

• Registration Number: NCT05773235
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-02-09
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Study First Posted: 2023-03-17
• Last Update Posted: 2023-03-17
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	Combined 3- and 7 Tesla-MRI	Clinically healthy persons of at least 55 years of age
Patients with intracerebral hemorrhage	Combined 3- and 7 Tesla-MRI	Patients with symptomatic intracranial hemorrhage (defined as non-traumatic intracerebral hemorrhage or convexity, non-aneurysmal subarachnoid hemorrhage) enrolled in the PRO-SVD study

Primary Outcome Measures

Name	Time	Method
Disease progression	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 Outcome Measures

Name	Time	Method
MRI-defined disease progression	24 months	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.
Increase in perivascular space severity scale	24 months	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).
Increase in number of SVD-attributable, ischaemic lesions	24 months	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.
Functional outcome	24 months	Modified Rankin Scale (ordinal scale, range 0-6 with 0 corresponding to no symptoms at all and 6 corresponding to death).
New cognitive impairment	24 months	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 .
Increase in number of SVD-attributable, haemorrhagic lesions	24 months	Composite outcome defined as any increase in numeric count for cerebral microbleeds and/or increase in cortical superficial siderosis multifocality score.
Clinical, vascular outcome event	24 months	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.

Trial Locations

Locations (1)

Department of Neurology, Inselspital Bern University Hospital; 🇨🇭 Bern, Switzerland