Actively Recruiting
Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-11-14
150
Participants Needed
8
Research Sites
485 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 at least one of the following: NT-proBNP >400 pg/mL, left atrial ventricular index >42 ml/m2, left atrial diameter >46 mm, or covert infarctions involving more than one vascular territory
- Signed written informed consent
- Presence of any clinically silent ischemic brain lesions detected by neuroimaging meeting established criteria including diffusion weighted imaging positive lesions, cavitatory lesions ≥3 mm, or specific T2/T1 weighted MRI lesion characteristics
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 such as pacemaker, implantable cardiac defibrillator, or implantable cardiac monitor
- Indication for implantation of cardiac implantable electronic devices
- History of or indication for major cardiac surgery or transcutaneous aortic valve implantation
- Indication for permanent oral anticoagulation
- Contraindication for permanent oral anticoagulation
- Life expectancy less than 2 years
- Active high-grade intra- or extracranial malignancy
- Participation in another clinical trial that affects this study's objectives
- Lack of accountability or inability to understand the study implications
- Inability to follow study procedures due to language, psychological disorders, dementia, or similar issues
- Known or suspected non-compliance, drug or alcohol abuse
AI-Screening
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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.
CONTACT
T
Thomas Meinel, Dr. med.
CONTACT
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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