Clinical trial Recruiting at 2 sites Observational Ages 16 and up

Understanding silent strokes and their risk factors

Official title: Prevalence of Attributable Etiology and Modifiable Stroke Risk Factors in Patients With Covert Brain Infarctions (CBI-registry)

Run by Insel Gruppe AG, University Hospital Bern · NCT05685069 · Data updated 2026-11-12

This study looks at silent strokes in patients to see what risk factors might help prevent future strokes and improve treatment.

Quick facts

Study typeObservational
Ages16 Years and up
SexAll
Enrollment230 (estimated)
SponsorInsel Gruppe AG, University Hospital Bern
Academic / other
Drugs / interventionsradiation
Locations2 sites (Tours and 1 other locations)
StatusRecruiting
StartedMarch 1, 2019
Main results expectedDecember 31, 2025
Study endsAugust 31, 2026
Registry record updatedNovember 14, 2024
Trial IDNCT05685069 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals with clinically silent ischemic lesions detected on neuroimaging.

Probably not a fit

Patients with overt ischemic strokes or those without any detectable ischemic lesions on imaging may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to investigate covert brain infarctions (CBI) by conducting a comprehensive workup similar to that for manifest ischemic strokes. Patients with CBI will undergo a standardized assessment that includes cerebral MRI, long-term ECG monitoring, echocardiography, and evaluation of vascular risk factors. The goal is to identify modifiable risk factors that could lead to better management and prevention of future strokes. By analyzing the data from 230 patients, the study seeks to provide insights into the prevalence and significance of these silent strokes.

Why it matters

Potential benefit: If successful, this study could lead to improved identification and management of stroke risk factors in patients with covert brain infarctions, potentially reducing the risk of future strokes.

How similar studies have gone: While there have been studies on overt strokes, this approach to covert brain infarctions is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Any clinically silent ischemic lesions of the brain parenchyma detected on neuroimaging defined according to established criteria as either:

  * DWI positive lesions: Focus of restricted diffusion (high DWI signal and low ADC value) occurring in either white or gray matter, located in the cerebrum, cerebellum, or brain stem AND not satisfying the diagnostic criteria for MS OR
  * Cavitatory Lesions: ≥ 3 mm in size that follow CSF on all sequences that are slit or wedge shaped with an irregular margin AND NOT longitudinally aligned with perforating vessels or with a multiple, bilateral symmetrical distribution OR
  * T2W hyperintense/T1W hypointense lesions: Focal lesion with high T2W signal and low T1W signal that have prior evidence of restricted diffusion; OR present within cortical gray matter or deep gray matter nuclei OR a lesion that is new, compared with an MRI performed within 3 months OR T2W hyper/T1W hypointense lesions in the white matter, which are discontinuous but associated with the classic confluent periventricular T2 intense change of leukoaraiosis (Fazekas ≥2) AND NOT satisfying the diagnostic criteria for MS or with a significant patient history of severe trauma, radiation, drug toxicity, or carbon monoxide poisoning
* Informed Consent as documented by signature by patient or legally authorized representative

Exclusion Criteria:

* Projected life expectancy of less than 2 years,
* Contraindication to MRI,
* Patients with a history of symptoms compatible with an AIS/TIA attributable to the lesion observed, covert neurological deficits are allowed,
* Patient is already included in another clinical trial that will affect the objectives of this study,
* Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly,
* Women who are pregnant or breast feeding or intention to become pregnant during the course of the study,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Contraindications to any of the routine procedures, e.g. inability to obtain neurovascular ultrasound examination,
* Known or suspected non-compliance, drug or alcohol abuse

Where it's running

  • Centre Hospitalier Universitaire de Tours
    Tours, France
    Recruiting
  • Inselspital Bern
    Bern, Switzerland
    Recruiting

Study contacts

  • Principal investigator: Urs Fischer, Prof. Dr. med. — Insel Gruppe AG, University Hospital Bern
  • Study coordinator: Urs Fischer, Prof. Dr. med.
  • Email: urs.fischer@insel.ch
  • Phone: +41 31 63 2 33 79

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Monitoring Atrial Fibrillation in Patients with Silent Brain Lesions

    This study is testing if older adults with unnoticed brain damage have a higher chance of developing atrial fibrillation by using a special heart monitor over two years.

    Recruiting at 6 sites Insel Gruppe AG, University Hospital Bern · Graz and 7 other locations · NCT04449523

  • Biomarkers That Signal Silent Strokes in High-Risk Cardiac Procedures

    This study tests whether blood biomarkers NSE and NFLs can predict silent brain injuries and later cognitive problems in adults having high-risk transcatheter heart procedures.

    Recruiting Aristotle University Of Thessaloniki · Thessaloniki · NCT07844850

  • NeuroFirst brain protection for adults having heart bypass surgery

    This trial tests whether a bundled anesthesia approach called NeuroFirst can help people aged 60 and older having planned heart surgery with cardiopulmonary bypass avoid silent brain infarcts and thinking or memory problems after surgery.

    Recruiting at 5 sites Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing, Beijing Municipality and 4 other locations · NCT07048002

  • Blood thinners and cholesterol medicines to prevent future brain events in people with hidden (covert) brain infarcts

    This trial will see if taking a blood thinner and/or a cholesterol‑lowering medicine lowers the chance of future stroke or dementia in people 50 and older who have MRI-detected covert brain infarcts but no prior stroke symptoms.

    Recruiting Phase 3 Aarhus University Hospital · Aalborg and 13 other locations · NCT07012629

  • Diagnosing neurocognitive complications during surgery using EEG

    This study is testing if using EEG during surgery can help doctors spot early signs of cognitive problems, like delirium, in adults having non-cardiac surgeries.

    Recruiting Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology · Moscow, Moscow Oblast · NCT06545786

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.