Prognosis of Cerebral Small Vessel Disease

Recruiting

• Conditions: Small Vessel Cerebrovascular Disease; CAA - Cerebral Amyloid Angiopathy; Cadasil; Cerebral Amyloid Angiopathy

• Registration Number: NCT05734378
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

Prognosis of small vessel disease (SVD) depends on the underlying type of SVD and index manifestation.

The aim of this prospective, observational cohort study is to determine the risk of different outcome events among patients with SVD according to the type of index presentation.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-17
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-08
• Primary Completion: 2030-11-30
• Study Completion: 2030-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Hypertensive deep perforator arteriolopathy (DPA), clinically symptomatic with either ICH, ischaemic stroke, cognitive impairment or severe radiological manifestation (Fazekas ≥II)
• Cerebral amyloid angiopathy (CAA according to modified Boston or Edinburgh criteria), clinically symptomatic with either ICH (including cSAH), amyloid spells, cognitive impairment or severe radiological manifestation (CMB≥2)
• Other SVD (i.e. CADASIL or other sporadic or genetic SVD)

Exclusion Criteria

• Life expectancy of <6 months due to not-SVD related causes (i.e. cancer)
• Patient is unlikely to attend follow-up visits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ischaemic stroke	1 year	Defined by CT and/or MRI
Cardio-vascular death	1 year	According to the treating physician
Intracerebral haemorrhage (ICH)	1 year	Non-traumatic, intracerebral haemorrhage (ICH, including convexity subarachnoid haemorrhage)

Secondary Outcome Measures

Name	Time	Method
Other intracranial bleeding	1 year	Subdural haematoma, subarachnoid haemorrhage
Other (transient) neurological attacks	1 year	Including transient ischaemic attack (TIA), transient neurological attack (TNA), amyloid spells, (focal) seizures
Functional outcome	1 year	Modified Rankin scale score (ordinal score, range 0-6, a score of 0 corresponds to no symptoms at all, while a score of 6 corresponds to death)
New-onset of extracranial vascular disease	1 year	As judged by the treating physician
Cognitive impairment	1 year	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.

Trial Locations

Locations (1)

Department of Neurology, Inselspital Bern University Hospital; 🇨🇭 Bern, Switzerland