NCT05734378

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Dec 2020Nov 2030

Study Start

First participant enrolled

December 1, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2030

Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

10 years

First QC Date

February 8, 2023

Last Update Submit

March 6, 2023

Conditions

Cerebral Amyloid AngiopathySmall Vessel Cerebrovascular DiseaseCadasilCAA - Cerebral Amyloid Angiopathy

Keywords

small vessel diseaseCAAcerebral amyloid angiopathyhypertensive arteriopathydeep perforator arteriopathyCADASIL

Outcome Measures

Primary Outcomes (3)

  • Intracerebral haemorrhage (ICH)

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

    1 year

  • Ischaemic stroke

    Defined by CT and/or MRI

    1 year

  • Cardio-vascular death

    According to the treating physician

    1 year

Secondary Outcomes (5)

  • Other intracranial bleeding

    1 year

  • Other (transient) neurological attacks

    1 year

  • Cognitive impairment

    1 year

  • New-onset of extracranial vascular disease

    1 year

  • Functional outcome

    1 year

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Inselspital Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Cerebral Amyloid AngiopathyCerebral Small Vessel DiseasesCADASILCerebral Amyloid Angiopathy, Familial

Condition Hierarchy (Ancestors)

Cerebral Arterial DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesCerebral InfarctionBrain InfarctionBrain IschemiaDementia, VascularStrokeDementiaGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicAmyloidosis, FamilialMetabolism, Inborn Errors

Study Officials

  • David J Seiffge, Prof, MD

    Department of Neurology, Inselspital Bern University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Kormann

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 17, 2023

Study Start

December 1, 2020

Primary Completion (Estimated)

November 30, 2030

Study Completion (Estimated)

November 30, 2030

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

CH(1)