Clinical trial NCT05773235: MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events
Official title: MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events - a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracerebral Hemorrhage
CAA - Cerebral Amyloid Angiopathy
Cerebral Small Vessel Diseases
Keywords: Intracerebral hemorrhage
Ischemic stroke
Cerebral amyloid angiopathy
Hypertensive deep perforator arteriopathy
7 Tesla-MRI
Cerebral small vessel disease
Ultra high-field MRI
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 consecutive patients with cerebral small vessel disease-related intracerebral hemorrhage admitted to the Inselspital Bern. Patients will undergo combined 3/7 Tesla-MRI according to a standardised small vessel disease MRI protocol at 3 timepoints.

A control group consisting of 10 clinically asymptomatic subjects will undergo the same MRI protocol at one timepoint.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disease progression
timeFrame: 24 months
Secondary outcomes:
measure: MRI-defined disease progression
timeFrame: 24 months
measure: Increase in number of SVD-attributable, ischaemic lesions
timeFrame: 24 months
measure: Increase in number of SVD-attributable, haemorrhagic lesions
timeFrame: 24 months
measure: Increase in perivascular space severity scale
timeFrame: 24 months
measure: Clinical, vascular outcome event
timeFrame: 24 months
measure: Functional outcome
timeFrame: 24 months
measure: New cognitive impairment
timeFrame: 24 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Neurology, Inselspital Bern University Hospital
Study officials:
affiliation: Department of Neurology, Inselspital Bern University Hospital
name: David J Seiffge, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References: