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

NCT ID: NCT05773235

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Combined 3- and 7 Tesla-MRI

Intervention Type: DIAGNOSTIC_TEST

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

Healthy controls

Clinically healthy persons of at least 55 years of age

Combined 3- and 7 Tesla-MRI

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Clinically healthy person ≥ 55 years
• Written informed consent provided by the healthy control
• 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

• 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J Seiffge, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Inselspital Bern University Hospital

Locations

Department of Neurology, Inselspital Bern University Hospital

Bern, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Marianne Kormann

Role: CONTACT

studien.stroke@insel.ch

+41 31 632 70 00

Facility Contacts

David J Seiffge, MD, Prof

Role: primary

david.seiffge@insel.ch

+41 31 632 70 00

Other Identifiers

2021-02006

Identifier Type: -

Identifier Source: org_study_id