Status:
RECRUITING
Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Silent Stroke
Silent Cerebral Infarct
Eligibility:
All Genders
50+ years
Brief 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 l...
Detailed Description
Arterial Fibrillation (AF) is well-recognized as a cause for cryptogenic Acute Ischemic Stroke (AIS) and searched for in clinical practice. However, although AF is associated with Silent Brain Infarct...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
September 8 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04449523
Start Date
September 8 2020
End Date
December 31 2029
Last Update
November 14 2024
Active Locations (8)
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1
Universitätsspital Graz
Graz, Austria
2
Charite Berlin
Berlin, Germany
3
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
4
Kantonsspital Aarau
Aarau, Switzerland