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Clinical Trials/NCT05734378
NCT05734378
Recruiting
Not Applicable

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

Insel Gruppe AG, University Hospital Bern1 site in 1 country900 target enrollmentDecember 1, 2020
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ConditionsCerebral Amyloid AngiopathySmall Vessel Cerebrovascular DiseaseCadasilCAA - Cerebral Amyloid Angiopathy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Amyloid Angiopathy
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
900
Locations
1
Primary Endpoint
Ischaemic stroke
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
November 30, 2030
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Ischaemic stroke

Time Frame: 1 year

Defined by CT and/or MRI

Cardio-vascular death

Time Frame: 1 year

According to the treating physician

Intracerebral haemorrhage (ICH)

Time Frame: 1 year

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

Secondary Outcomes

  • Functional outcome(1 year)
  • Other intracranial bleeding(1 year)
  • Other (transient) neurological attacks(1 year)
  • New-onset of extracranial vascular disease(1 year)
  • Cognitive impairment(1 year)

Study Sites (1)

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