NCT04449523 Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions
| NCT ID | NCT04449523 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Silent Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2020-09-08 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2020-09-08 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Laurent Roten, PD Dr. med.
PRINCIPAL INVESTIGATOR
Inselgruppe AG
Frequently Asked Questions
Who can join the NCT04449523 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Silent Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04449523 currently recruiting?
Yes, NCT04449523 is actively recruiting participants. Contact the research team at laurent.roten@insel.ch for enrollment information.
Where is the NCT04449523 trial being conducted?
This trial is being conducted at Graz, Austria, Berlin, Germany, Lausanne, Switzerland, Aarau, Switzerland and 4 additional locations.
Who is sponsoring the NCT04449523 clinical trial?
NCT04449523 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Laurent Roten, PD Dr. med. at Inselgruppe AG. The trial plans to enroll 150 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.