Tracks heart rhythm for atrial fibrillation in people with silent brain lesions
Checks heart rhythm over 24 months in adults with silent brain lesions from past strokes.
Plain-language title generated from the registry record
Registry title: Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions
Key facts
- Where
- Graz, AustriaSee the site
Where in Austria
- Universitätsspital GrazGraz, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Insel Gruppe AG, University Hospital Bern
- Trial code
- NCT04449523
- Record updated
- 14 November 2024
- Original description
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.Read full original descriptionShow less
Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions (SILENT2)
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.
Inclusion: 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: Known or suspected non-compliance, drug or alcohol abuse; 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; Active intra- or extracranial high-grade malignancy; Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc; Indication for permanent oral anticoagulation; Contraindication for permanent oral anticoagulation; Projected life expectancy of less than 2 years; 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.