ClinicalTrials.gov record NCT05734378

Prognosis of Cerebral Small Vessel Disease

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Mar 8, 2023, about 3 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age16 years old and older
SexAll
LocationSwitzerland
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational cohort study follows people with different types of cerebral small vessel disease for one year to measure clinical outcomes. It includes patients with cerebral amyloid angiopathy, small vessel cerebrovascular disease, and CADASIL. Researchers will record events such as intracerebral haemorrhage, ischemic stroke, cardiovascular death, other intracranial bleeding, transient neurological attacks, cognitive impairment, new extracranial vascular disease, and functional outcome.

What it is studying. The study tests how the type of small vessel disease and the patient's initial presentation relate to the risk of bleeding, ischemic stroke, cardiovascular death, cognitive impairment, and functional outcome over one year.

What the researchers hope to learn. Scientific goals: to determine the one-year risk of intracerebral haemorrhage, ischaemic stroke, and cardiovascular death by type of small vessel disease and index presentation; to describe rates of other intracranial bleeding, transient neurological events, cognitive impairment (MoCA <26 or new daily living impairment), new extracranial vascular disease, and functional outcome (modified Rankin Scale).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are followed for one year to record outcomes including intracerebral haemorrhage, ischemic stroke, cardiovascular death, other intracranial bleeding, transient neurological attacks, cognitive impairment, new extracranial vascular disease, and functional outcome. Assessments named in the record include review of clinical events and imaging (CT and/or MRI) to define stroke, cognitive testing with the Montreal Cognitive Assessment (MoCA), and functional scoring with the modified Rankin Scale. The registry requires that you already meet the study's diagnostic or radiological criteria for a type of small vessel disease; the record does not say the study will perform the diagnostic imaging or tests used to establish that diagnosis. The record does not list any invasive specimen-collection procedures during participation.

How the study is structured. A prospective, observational cohort: people with specified small vessel diseases are followed without assigned treatment. Data on predefined outcomes are collected during the one-year follow-up and analyzed by disease type and index presentation. No experimental treatments are given as part of the study; the study records clinical events and assessments (including cognitive testing and functional outcome) at planned times within one year.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Cerebral Amyloid Angiopathy; Small Vessel Cerebrovascular Disease; Cadasil; CAA - Cerebral Amyloid Angiopathy. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Switzerland. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Dec 1, 2020
Primary completion
Nov 30, 2030 (estimated)
Study completion
Nov 30, 2030 (estimated)
Target enrollment
900 participants (estimated)
Last updated on registry
Mar 8, 2023
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Insel Gruppe AG, University Hospital Bern

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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