ClinicalTrials.gg
RecruitingNCT05734378PRO-SVDUpdated Mar 8, 2023

Prognosis of Cerebral Small Vessel Disease

An observational study in Cerebral Amyloid Angiopathy, Small Vessel Cerebrovascular Disease and Cadasil, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

From the registry’s dates

  • Started Dec 2020; still recruiting 5 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
900
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • small vessel disease
  • CAA
  • cerebral amyloid angiopathy
  • hypertensive arteriopathy
  • deep perforator arteriopathy
  • CADASIL
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In context

Cerebral Amyloid Angiopathy

37 studies on the registry are indexed under Cerebral Amyloid Angiopathy; 8 are open to participants now.

This study's planned enrollment of 900 is above the median of 81 across 18 observational studies indexed under Cerebral Amyloid Angiopathy.

Browse Cerebral Amyloid Angiopathy studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • of \<6 months due to not-SVD related causes (i.e. cancer)
  • Patient is unlikely to attend follow-up visits
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
900 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. Intracerebral haemorrhage (ICH)

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

    Time frame: 1 year

  2. Ischaemic stroke

    Defined by CT and/or MRI

    Time frame: 1 year

  3. Cardio-vascular death

    According to the treating physician

    Time frame: 1 year

Secondary outcomes

  1. Other intracranial bleeding

    Subdural haematoma, subarachnoid haemorrhage

    Time frame: 1 year

  2. Other (transient) neurological attacks

    Including transient ischaemic attack (TIA), transient neurological attack (TNA), amyloid spells, (focal) seizures

    Time frame: 1 year

  3. 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.

    Time frame: 1 year

  4. New-onset of extracranial vascular disease

    As judged by the treating physician

    Time frame: 1 year

  5. 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)

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Department of Neurology, Inselspital Bern University Hospital
    Bern, 3010, Switzerland
    Recruiting
    • David J Seiffge, MD, Prof · Contactdavid.seiffge@insel.ch · +41 31 632 70 00
    • Martina B Goeldlin, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05734378
Responsible party
Sponsor
First posted
Feb 17, 2023
Start date
Dec 1, 2020
Primary completion
Nov 30, 2030 (estimated)
Completion
Nov 30, 2030 (estimated)
Last update
Mar 8, 2023

Study contacts

Marianne Kormann
Contact
studien.stroke@insel.ch
+41 31 632 70 00
David J Seiffge, Prof, MD
principal investigator · Department of Neurology, Inselspital Bern University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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