Prognosis of Cerebral Small Vessel Disease

Cerebral Amyloid Angiopathy Clinical Trial

— PRO-SVD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734378
• Other study ID #: 2020-02535
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: November 30, 2030

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: Marianne Kormann
• Phone: +41 31 632 70 00
• Email: studien.stroke[@]insel.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: November 30, 2030
• Est. primary completion date: November 30, 2030
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cadasil
• Cerebral Amyloid Angiopathy
• Cerebral Small Vessel Diseases
• Cerebrovascular Disorders
• Dementia, Multi-Infarct
• Small Vessel Cerebrovascular Disease

Locations

Country	Name	City	State
Switzerland	Department of Neurology, Inselspital Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracerebral haemorrhage (ICH)	Non-traumatic, intracerebral haemorrhage (ICH, including convexity subarachnoid haemorrhage)	1 year
Primary	Ischaemic stroke	Defined by CT and/or MRI	1 year
Primary	Cardio-vascular death	According to the treating physician	1 year
Secondary	Other intracranial bleeding	Subdural haematoma, subarachnoid haemorrhage	1 year
Secondary	Other (transient) neurological attacks	Including transient ischaemic attack (TIA), transient neurological attack (TNA), amyloid spells, (focal) seizures	1 year
Secondary	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.	1 year
Secondary	New-onset of extracranial vascular disease	As judged by the treating physician	1 year
Secondary	Functional outcome	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)	1 year