Actively Recruiting
Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions (SILENT2)
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-11-14
150
Participants Needed
8
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the role of Arterial Fibrillation (AF) in patients with Silent Brain Infarction (SBI), a condition where brain lesions occur without obvious symptoms. While AF is a well-known cause of cryptogenic Acute Ischemic Stroke (AIS), its impact on SBI formation is less clear and requires further study. The main goal is to compare the incidence of AF diagnosis over 24 months between patients with SBI and those with cryptogenic AIS to better understand AF's role in these silent brain lesions. Participants aged 65 or older, or those 50 and older with specific heart-related markers, who have clinically silent ischemic brain lesions identified by MRI, will receive a subcutaneous cardiac monitor implant called Reveal LINQ. This device continuously tracks heart rhythms and transmits data to physicians via the Medtronic MyCareLink system. The study monitors for various heart rhythm irregularities, including episodes of AF lasting 30 seconds or longer, and other significant arrhythmias. Relevant findings are reviewed within one week and communicated to patients and their doctors within two weeks. During the study, researchers will assess the cumulative incidence of AF diagnosis over 24 months and also measure times to first AF diagnosis, AF burden, stroke occurrence, mortality, and other heart-related conditions. Brain MRI scans may be repeated at 24 months if funding allows. Patients provide informed consent and undergo regular evaluations while their heart rhythm data is continuously monitored to help clarify AF's role in silent brain infarctions. The study aims to inform care strategies for SBI, potentially improving patient management.
CONDITIONS
Brief Title
Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Age 50 years or older with one of the following: NT-proBNP >400 pg/mL, left atrial ventricular index >42 ml/m2 or left atrial diameter >46 mm, or covert infarctions with cortical involvement in more than one vascular territory
- Written informed consent
- Presence of any clinically silent ischemic brain lesions detected by neuroimaging meeting specific MRI criteria
You will not qualify if you...
- History of atrial fibrillation or atrial flutter
- History of symptoms compatible with acute ischemic stroke (covert neurological deficits allowed)
- Presence of cardiac implantable electronic devices (pacemaker, ICD, ICM)
- Indication for cardiac implantable electronic device implantation
- 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 less than 2 years
- Active high-grade malignancy
- Participation in another clinical trial affecting study objectives
- Lack of accountability or inability to understand the study
- Inability to follow study procedures due to language, psychological, or cognitive issues
- Known or suspected non-compliance, drug or alcohol abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive a subcutaneous implantation of a cardiac monitor (Reveal LINQ) to detect arrhythmias and silent atrial fibrillation.
Continuous monitoring with data transmitted regularly to physicians
Duration - Up to 24 months
Participants are monitored over time for the occurrence of atrial fibrillation and other arrhythmias through the implanted cardiac monitor, with relevant findings communicated to their treating physicians.
Ongoing remote monitoring with periodic follow-up as needed
Trial Site Locations
Total: 8 locations
1
Universitätsspital Graz
Graz, Austria
Actively Recruiting
2
Charite Berlin
Berlin, Germany
Not Yet Recruiting
3
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
4
Kantonsspital Aarau
Aarau, Switzerland
Active, Not Recruiting
5
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
6
Inselspital Bern
Bern, Switzerland, 3010
Actively Recruiting
7
Kantonsspital St.Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
8
Universitätsspital Zurich
Zurich, Switzerland
Actively Recruiting
Research Team
L
Laurent Roten, PD Dr. med.
T
Thomas Meinel, Dr. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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