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NCT Number: NCT05734378

Prognosis of Cerebral Small Vessel Disease

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.

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Key information

Conditions

Cerebral Amyloid Angiopathy Amyloidosis Amyloidosis, Familial Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Brain Infarction Brain Ischemia CAA - Cerebral Amyloid Angiopathy CADASIL Cardiovascular Diseases Central Nervous System Diseases Cerebral Amyloid Angiopathy, Familial Cerebral Arterial Diseases Cerebral Infarction Cerebral Small Vessel Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dementia, Vascular Genetic Diseases, Inborn Infarction Intracranial Arterial Diseases Ischemia Metabolic Diseases Metabolism, Inborn Errors Necrosis Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Small Vessel Cerebrovascular Disease Stroke Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, Inselspital Bern University Hospital

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

David J Seiffge, MD, Prof

CONTACT

[email protected]

+41 31 632 70 00

Martina B Goeldlin, MD

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intracerebral haemorrhage (ICH)

    Time frame: 1 year

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

  2. Ischaemic stroke

    Time frame: 1 year

    Defined by CT and/or MRI

  3. Cardio-vascular death

    Time frame: 1 year

    According to the treating physician

Secondary outcomes

  1. Other intracranial bleeding

    Time frame: 1 year

    Subdural haematoma, subarachnoid haemorrhage

  2. Other (transient) neurological attacks

    Time frame: 1 year

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

  3. Cognitive impairment

    Time frame: 1 year

    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.

  4. New-onset of extracranial vascular disease

    Time frame: 1 year

    As judged by the treating physician

  5. Functional outcome

    Time frame: 1 year

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Marianne Kormann

CONTACT

[email protected]

+41 31 632 70 00

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: PRO-SVD

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Feb 17, 2023
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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