Prognosis of Cerebral Small Vessel Disease

Prognosis of Cerebral Small Vessel Disease - a Prospective Cohort Study (PRO-SVD)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05734378

Acronym

PRO-SVD

Enrollment

900

Registered

2023-02-17

Start date

2020-12-01

Completion date

2030-11-30

Last updated

2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CAA - Cerebral Amyloid Angiopathy, Cadasil, Cerebral Amyloid Angiopathy, Small Vessel Cerebrovascular Disease

Keywords

small vessel disease, CAA, cerebral amyloid angiopathy, hypertensive arteriopathy, deep perforator arteriopathy, CADASIL

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
New-onset of extracranial vascular disease	1 year	As judged by the treating physician
Other intracranial bleeding	1 year	Subdural haematoma, subarachnoid haemorrhage
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)
Other (transient) neurological attacks	1 year	Including transient ischaemic attack (TIA), transient neurological attack (TNA), amyloid spells, (focal) seizures
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.

Countries

Switzerland

Contacts

Primary ContactMarianne Kormann

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

Outcome results