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

NCT05685069 | Recruiting

• 1 other identifier: 2019-00293
• Study Type: observational
• Target: 230
• Locations: 2 countries
• Sites: 2

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.

Conditions

Silent Stroke; Silent Cerebral Infarct; Covert Brain Infarct; Covert Brain Infarction; Lacune; Silent Brain Infarction

Keywords

Covert brain infarction; Covert cerebrovascular disease; Ischemic stroke

Outcome Measures

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)

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

Secondary Outcomes (19)

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

  At the end of follow-up (2 years)

• Median of National Institute of Health Stroke score (NIHSS)

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

• Percentage of Presence of covert neurological deficits corresponding to the CBI

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

• Median of Modified Rankin Scale functional status (mRS)

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

• Median of Montreal Cognitive Assessment (MOCA)

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

Study Arms (1)

Standardized work-up

A standardized workup procedures including cerebral MRI, long-term rhythm monitoring (3 x 7 days ECG), echocardiography, stroke laboratory, risk factor assessment and noninvasive angiography of the cervical and intracranial arteries will be performed.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (2)

Centre Hospitalier Universitaire de Tours

Tours, France

RECRUITING

Inselspital Bern

Bern, Switzerland

RECRUITING

Related Publications (1)

• Meinel TR, Kaesmacher J, Roten L, Fischer U. Covert Brain Infarction: Towards Precision Medicine in Research, Diagnosis, and Therapy for a Silent Pandemic. Stroke. 2020 Aug;51(8):2597-2606. doi: 10.1161/STROKEAHA.120.030686. Epub 2020 Jul 10. No abstract available.

  PMID: 32646332 BACKGROUND

Related Links

• Substudy offering implantable cardiac monitors to patients with CBI and high risk for atrial fibrillation

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Urs Fischer, Prof. Dr. med.

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Urs Fischer, Prof. Dr. med.

CONTACT

+41 31 63 2 33 79; urs.fischer@insel.ch

Thomas Meinel, Dr. med.

CONTACT

+41 31 66 4 25 67; thomas.meinel@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 13, 2023
• Study Start: March 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: From 2022 onwards
• Access Criteria: After clearance by ethics

Locations

CH (1); FR (1)