Monitoring Atrial Fibrillation in Patients with Silent Brain Lesions

Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions (SILENT2)

This study is testing if older adults with unnoticed brain damage have a higher chance of developing atrial fibrillation by using a special heart monitor over two years.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (other)
• Drugs / interventions: radiation
• Locations: 8 sites (Graz and 7 other locations)
• Trial ID: NCT04449523 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the incidence of atrial fibrillation (AF) in patients aged 65 and older who have clinically silent brain ischemic lesions. Participants will undergo continuous rhythm monitoring through a subcutaneously implanted cardiac monitor to assess the cumulative incidence of AF over 24 months. The study seeks to clarify the relationship between silent brain infarctions and the occurrence of AF, comparing the rates of AF diagnosis in these patients to those with cryptogenic acute ischemic stroke. The findings could enhance understanding of AF's role in silent strokes and improve patient management.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 65 years and older with clinically silent ischemic lesions detected on brain imaging.

Not a fit: Patients without clinically silent ischemic lesions or those under 50 years of age may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better identification and management of atrial fibrillation in patients with silent brain lesions, potentially reducing the risk of future strokes.

How similar studies have performed: While the relationship between atrial fibrillation and silent strokes has been explored, this specific approach of continuous monitoring in patients with silent brain lesions is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Graz and 7 other locations

• Universitätsspital Graz — Graz, Austria (RECRUITING)
• Charite Berlin — Berlin, Germany (NOT_YET_RECRUITING)
• Centre hospitalier universitaire vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (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)

Study contacts

• Principal investigator: Laurent Roten, PD Dr. med. — Inselgruppe AG
• Study coordinator: Laurent Roten, PD Dr. med.

Conditions: Silent Stroke, Silent Cerebral Infarct, Fibrillation