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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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,

Trial population

Patients will be recruited by the Neuroradiology Department of Inselspital Bern. All patients undergoing a brain MRI showing a presumably silent brain lesion and fulfilling the inclusion/exclusion criteria will be eligible for the study. Inpatients will be contacted while on a ward and outpatients by telephone calls.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

230 Participants
are grouped into 1 trial group
Group A: Standardized work-up

Trial outcomes

Primary outcomes

1

Percentage of Modified Trial of Org 10172 in Acute Stroke Treatment etiology

Incorporating results from the baseline work-up the most likely etiology according to the modified Trial of Org 10172 in Acute Stroke Treatment (TOAST) for the chronic brain lesions observed will be rated: * Large vessel atherothrombotic stroke: \>=50% ipsilateral vascular stenosis present * Cardiac embolism: Sustained or paroxysmal atrial fibrillation or atrial flutter and/or Structural or functional high-risk source of embolism * Small vessel (lacunar) stroke: ischemia in perforating brain artery without embolic source * Patent foramen ovale (PFO): PFO with or without atrial septal aneurysm with recommendation for closure (patient age \<60 OR patient age 60-70 and Risk of Paradoxical Embolism (RoPE) Score ≥5 * Other specific etiology (e.g. dissections) * Stroke of undetermined etiology (two or more causes identified, negative evaluation)

Time frame
After baseline work-up, expected to be at least 3 months after brain imaging

Secondary outcomes

1

Percentage of Modified Trial of Org 10172 in Acute Stroke Treatment etiology

Incorporating results from the baseline work-up the most likely etiology according to the modified Trial of Org 10172 in Acute Stroke Treatment (TOAST) for the chronic brain lesions observed will be rated: * Large vessel atherothrombotic stroke: \>=50% ipsilateral vascular stenosis present * Cardiac embolism: Sustained or paroxysmal atrial fibrillation or atrial flutter and/or Structural or functional high-risk source of embolism * Small vessel (lacunar) stroke: ischemia in perforating brain artery without embolic source * Patent foramen ovale (PFO): PFO with or without atrial septal aneurysm with recommendation for closure (patient age \<60 OR patient age 60-70 and Risk of Paradoxical Embolism (RoPE) Score ≥5 * Other specific etiology (e.g. dissections) * Stroke of undetermined etiology (two or more causes identified, negative evaluation)

Time frame
At the end of follow-up (2 years)
2

Median of National Institute of Health Stroke score (NIHSS)

The NIHSS is a 15-item neurological examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities, without coaching and without making assumptions about what the patient can do. Ratings for each item are scored on a 3- to 5-point scale, with 0 as normal, and there is an allowance for untestable items. Scores range from 0 to 42, with higher scores indicating greater severity.

Time frame
At baseline visit, expected to be at least 3 months after brain imaging
3

Percentage of Presence of covert neurological deficits corresponding to the CBI

Unrecognized or unreported stroke-like symptoms, called covert symptoms, e.g. visual field defect or slight ataxia

Time frame
At baseline visit, expected to be at least 3 months after brain imaging
4

Median of Modified Rankin Scale functional status (mRS)

The Modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death.

Time frame
At baseline visit, expected to be at least 3 months after brain imaging

Other outcomes

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