Understanding silent strokes and their risk factors
Prevalence of Attributable Etiology and Modifiable Stroke Risk Factors in Patients With Covert Brain Infarctions (CBI-registry)
This study looks at silent strokes in patients to see what risk factors might help prevent future strokes and improve treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 230 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Tours and 1 other locations) |
| Trial ID | NCT05685069 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with clinically silent ischemic lesions detected on neuroimaging.
Not a fit: Patients with overt ischemic strokes or those without any detectable ischemic lesions on imaging may not benefit from this study.
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 performed: While there have been studies on overt strokes, this approach to covert brain infarctions is relatively novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Tours and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.