NCT05685069 Prevalence of Attributable Etiology and Modifiable Stroke Risk Factors in Patients With Covert Brain Infarctions
| NCT ID | NCT05685069 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Silent Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 230 participants |
| Start Date | 2019-03-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 230 participants in total. It began in 2019-03-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The CBI registry is a prospective, interdisciplinary, multimodal observational registry of patients with covert brain infarction. Methods: A standardized workup in analogy to manifest ischemic stroke including cerebral MRI, long-term rhythm monitoring (3 x 7 days ECG), echocardiography, laboratory work-up and risk factor assessment as well as noninvasive angiography of the cervical and intracranial arteries will be performed.
Eligibility 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
Contact & Investigator
Urs Fischer, Prof. Dr. med.
PRINCIPAL INVESTIGATOR
Insel Gruppe AG, University Hospital Bern
Frequently Asked Questions
Who can join the NCT05685069 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Silent Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05685069 currently recruiting?
Yes, NCT05685069 is actively recruiting participants. Contact the research team at urs.fischer@insel.ch for enrollment information.
Where is the NCT05685069 trial being conducted?
This trial is being conducted at Tours, France, Bern, Switzerland.
Who is sponsoring the NCT05685069 clinical trial?
NCT05685069 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Urs Fischer, Prof. Dr. med. at Insel Gruppe AG, University Hospital Bern. The trial plans to enroll 230 participants.
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