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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

• Study Contact: Name: Marianne Kormann; Phone Number: +41 31 632 70 00; Email: studien.stroke@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Department of Neurology, Inselspital Bern University Hospital
    • Contact: David J Seiffge, MD, Prof; Phone Number: +41 31 632 70 00; Email: david.seiffge@insel.ch
    • Sub-Investigator: Martina B Goeldlin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracerebral haemorrhage (ICH)	Non-traumatic, intracerebral haemorrhage (ICH, including convexity subarachnoid haemorrhage)	1 year
Ischaemic stroke		1 year
Cardio-vascular death		1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other intracranial bleeding	Subdural haematoma, subarachnoid haemorrhage	1 year
Other (transient) neurological attacks	Including transient ischaemic attack (TIA), transient neurological attack (TNA), amyloid spells, (focal) seizures	1 year
Cognitive impairment		1 year
New-onset of extracranial vascular disease		1 year
Functional outcome	Modified Rankin scale score	1 year

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: David J Seiffge, Prof, MD, Department of Neurology, Inselspital Bern University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): November 30, 2030
• Study Completion (Anticipated): November 30, 2030

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: CADASIL; small vessel disease; cerebral amyloid angiopathy; CAA; hypertensive arteriopathy; deep perforator arteriopathy
• Additional Relevant MeSH Terms: Mental Disorders; Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Genetic Diseases, Inborn; Brain Ischemia; Proteostasis Deficiencies; Metabolism, Inborn Errors; Dementia; Brain Diseases, Metabolic; Infarction; Stroke; Brain Infarction; Brain Diseases, Metabolic, Inborn; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Amyloidosis, Familial; Cerebral Infarction; Dementia, Vascular; Amyloidosis; Cerebrovascular Disorders; Cerebral Small Vessel Diseases; Cerebral Amyloid Angiopathy; Cerebral Amyloid Angiopathy, Familial; CADASIL; Dementia, Multi-Infarct
• Other Study ID Numbers: 2020-02535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No