Recruiting
Observational
Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions
Condition(s) studied
Silent StrokeSilent Cerebral InfarctFibrillation
Study summary
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
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 Germany