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

NCT05773235 | Unknown

• 1 other identifier: 2021-02006
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• MRI-defined disease progression

  24 months

• Increase in number of SVD-attributable, ischaemic lesions

  24 months

• Increase in number of SVD-attributable, haemorrhagic lesions

  24 months

• Increase in perivascular space severity scale

  24 months

• Clinical, vascular outcome event

  24 months

Study Arms (2)

Patients with intracerebral hemorrhage

Patients with symptomatic intracranial hemorrhage (defined as non-traumatic intracerebral hemorrhage or convexity, non-aneurysmal subarachnoid hemorrhage) enrolled in the PRO-SVD study

Diagnostic Test: Combined 3- and 7 Tesla-MRI

Healthy controls

Clinically healthy persons of at least 55 years of age

Diagnostic Test: Combined 3- and 7 Tesla-MRI

Interventions

Combined 3- and 7 Tesla-MRI DIAGNOSTIC_TEST

7 Tesla-MRI including the following sequences: susceptibility weighted imaging (SWI), T1, T2, FLAIR, quantitative mapping sequences (T1mapping, qSM)

Healthy controls; Patients with intracerebral hemorrhage

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient participating in the PRO-SVD cohort
• Symptomatic intracranial hemorrhage
• Written informed consent provided by patient or next-of-kin
• No contraindications against MRI

You may not qualify if:

• Patient unsuitable for MRI follow-ups (e.g. claustrophobia)
• Patients unlikely to attend 1-year follow-up
• For healthy controls
• Clinically healthy person ≥ 55 years
• Written informed consent provided by the healthy control
• No contraindications against MRI
• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Neurology, Inselspital Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage; Cerebral Amyloid Angiopathy, Familial; Cerebral Small Vessel Diseases; Ischemic Stroke; Cerebral Amyloid Angiopathy

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Amyloidosis, Familial; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Stroke

Study Officials

• David J Seiffge, Prof, MD

  Department of Neurology, Inselspital Bern University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Kormann

CONTACT

+41 31 632 70 00; studien.stroke@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 17, 2023
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)