CAA - Cerebral Amyloid Angiopathy, Cerebral Small Vessel Diseases, Intracerebral Hemorrhage
Conditions
Keywords
Intracerebral hemorrhage, Ischemic stroke, Cerebral amyloid angiopathy, Hypertensive deep perforator arteriopathy, 7 Tesla-MRI, Cerebral small vessel disease, Ultra high-field MRI
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.
Interventions
DIAGNOSTIC_TESTCombined 3- and 7 Tesla-MRI
7 Tesla-MRI including the following sequences: susceptibility weighted imaging (SWI), T1, T2, FLAIR, quantitative mapping sequences (T1mapping, qSM)
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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. |
| 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 . |
| 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. |
Countries
Switzerland
Contacts
Primary ContactMarianne Kormann
Outcome results
None listed