Prognosis of Cerebral Small Vessel Disease | NCT05734378

Studies
Prognosis of Cerebral Small Vessel Disease

NCT05734378

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Recruiting

Last Update Posted

Mar 8, 2023Actual

Enrollment

900Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Nov 30, 2030Estimated

Completion Date

Nov 30, 2030Estimated

First Submitted Date

Feb 8, 2023

First Submission Date that Met QC Criteria

Feb 8, 2023

First Posted Date

Feb 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2023

Last Update Posted Date

Mar 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

900Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marianne Kormann	Contact	+41 31 632 70 00		studien.stroke@insel.ch

Overall Officials

Name	Affiliation	Role
David J Seiffge, Prof, MD	Department of Neurology, Inselspital Bern University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Inselspital Bern University Hospital	Recruiting	Bern		3010	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016657	Cerebral Amyloid Angiopathy
D059345	Cerebral Small Vessel Diseases
D046589	CADASIL
D028243	Cerebral Amyloid Angiopathy, Familial

Ancestor Terms

ID	Term
D002539	Cerebral Arterial Diseases
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided