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NCT05685069Recruiting

Prevalence of Attributable Etiology and Modifiable Stroke Risk Factors in Patients With Covert Brain Infarctions

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

Source: ClinicalTrials.gov · Last updated 14 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
230 (estimated)
First submitted
21 Dec 2022
Start date
1 Mar 2019
Primary completion date
31 Dec 2025
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Diseases
Stroke
NCT number
NCT05685069

What you commit to

  • Study type: Observational
  • Planned participants: 230
  • From 1 Mar 2019 to the primary completion date, 31 Dec 2025
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known or suspected non-compliance, drug or alcohol abuse

Other illness

  • Patients with a history of symptoms compatible with an AIS/TIA attributable to the lesion observed, covert neurological deficits are allowed,
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,

Other

  • Projected life expectancy of less than 2 years,
  • Contraindication to MRI,
  • 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,
  • Contraindications to any of the routine procedures, e.g. inability to obtain neurovascular ultrasound examination,

Who the study is looking for

  • 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

Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Inselspital Bern
Coordinator of this site? Confirm its status
BernSwitzerlandRecruiting
Centre Hospitalier Universitaire de Tours
Coordinator of this site? Confirm its status
ToursFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.