Prognosis of Cerebral Small Vessel Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Life expectancy of <6 months due to not-SVD related causes (i.e. cancer)

Patient is unlikely to attend follow-up visits

Trial population

This is a prospectively recruited cohort of patients treated with cerebral small vessel disease at Inselspital Bern University Hospital. Patients are recruited at the emergency department, neurology in-patient ward, Stroke Unit, IMC, ICU and outpatient clinics.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Intracerebral haemorrhage (ICH)

Non-traumatic, intracerebral haemorrhage (ICH, including convexity subarachnoid haemorrhage)

Time frame
1 year
2

Ischaemic stroke

Defined by CT and/or MRI

Time frame
1 year
3

Cardio-vascular death

According to the treating physician

Time frame
1 year

Secondary outcomes

1

Other intracranial bleeding

Subdural haematoma, subarachnoid haemorrhage

Time frame
1 year
2

Other (transient) neurological attacks

Including transient ischaemic attack (TIA), transient neurological attack (TNA), amyloid spells, (focal) seizures

Time frame
1 year
3

Cognitive impairment

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.

Time frame
1 year
4

New-onset of extracranial vascular disease

As judged by the treating physician

Time frame
1 year

Other outcomes

Sponsors and contacts

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