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

Intracerebral Hemorrhage Clinical Trial

— MRI-PRO-SVD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773235
• Other study ID #: 2021-02006
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: Marianne Kormann
• Phone: +41 31 632 70 00
• Email: studien.stroke[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Amyloid Angiopathy
• Cerebral Hemorrhage
• Cerebral Small Vessel Diseases
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Diagnostic Test:
• Combined 3- and 7 Tesla-MRI
7 Tesla-MRI including the following sequences: susceptibility weighted imaging (SWI), T1, T2, FLAIR, quantitative mapping sequences (T1mapping, qSM)

Locations

Country	Name	City	State
Switzerland	Department of Neurology, Inselspital Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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).	24 months
Secondary	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.	24 months
Secondary	Functional outcome	Modified Rankin Scale (ordinal scale, range 0-6 with 0 corresponding to no symptoms at all and 6 corresponding to death).	24 months
Secondary	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 .	24 months