Arterial Fibrillation (AF) is well-recognized as a cause for cryptogenic Acute Ischemic Stroke (AIS) and is associated with Silent Brain Infarction (SBI). However, the role of AF in the formation of lesions (SBIs) is less well established than its role in AIS and needs clarification.
The investigators hypothesize that continuous rhythm monitoring will yield a similar incidence of AF diagnosis in patients with SBI as compared to patients with cryptogenic AIS.
The primary objective is to assess the cumulative incidence of AF diagnosis at 24 months in patients with SBI.
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age
* ≥ 65 years
* ≥ 50 years AND one the following:
* NT-proBNP \>400 pg/mL
* Left atrial ventricular index \>42 ml/m2 or left atrial diameter \>46 mm
* Covert infarctions with cortical involvement in more than one vascular territory (left carotid territory, right carotid territory, vertebrobasilar territory)
* Written informed Consent
* Any clinically silent ischemic lesions of the brain parenchyma detected on neuroimaging defined according to established criteria as either:
* Diffusion weighted imaging (DWI) positive lesions: Focus of restricted diffusion (high DWI signal and low apparent diffusion coefficient value) occurring in either white or gray matter, located in the cerebrum, cerebellum, or brain stem AND not satisfying the diagnostic criteria for multiple sclerosis OR
* Cavitatory Lesions: ≥ 3 mm in size that follow cerebro-spinal fluid 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
* T2 weighted (T2W) hyperintense/T1 weighted (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 multiple sclerosis or with a significant patient history of severe trauma, radiation, drug toxicity, or carbon monoxide poisoning
Exclusion Criteria:
* History of AF or atrial flutter
* Patients with a history of symptoms compatible with an AIS, covert neurological deficits are allowed.
* Cardiac implantable electronic devices (pacemaker, implantable cardiac defibrillator (ICD), implantable cardiac monitor (ICM))
* Indication for cardiac implantable electronic device implantation (pacemaker, ICD, ICM)
* History of or indication for major cardiac surgery or transcutaneous aortic valve implantation
* Indication for permanent oral anticoagulation
* Contraindication for permanent oral anticoagulation
* Projected life expectancy of less than 2 years
* Active intra- or extracranial high-grade malignancy
* 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
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
* Known or suspected non-compliance, drug or alcohol abuse
Primary outcome measure(s)
Cumulative incidence of Arterial Fibrillation (AF) diagnosis over a median of 24 months — From day 0 to 24 months after inclusion Only adjudicated events will be used for the analysis. An AF episode is defined as lasting more than 30 seconds. A diagnosis of atrial flutter will also be considered as a primary endpoint.
Trial sites (8)
Facility
City
Region
Status
Universitätsspital Graz
Graz
Austria
Recruiting
Charite Berlin
Berlin
Germany
Not Yet Recruiting
Centre hospitalier universitaire vaudois (CHUV)
Lausanne
Canton of Vaud
Recruiting
Kantonsspital Aarau
Aarau
Switzerland
Active Not Recruiting
University Hospital Basel
Basel
Switzerland
Recruiting
Inselspital Bern
Bern
Switzerland
Recruiting
Kantonsspital St.Gallen
Sankt Gallen
Switzerland
Recruiting
Universitätsspital Zurich
Zurich
Switzerland
Recruiting
More Insel Gruppe AG, University Hospital Bern trials in Austria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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