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

Status: Recruiting
Location: See all (8) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Universitätsspital Graz
RECRUITING
Graz
Germany
Charite Berlin
NOT_YET_RECRUITING
Berlin
Switzerland
Kantonsspital Aarau
ACTIVE_NOT_RECRUITING
Aarau
University Hospital Basel
RECRUITING
Basel
Inselspital Bern
RECRUITING
Bern
Centre hospitalier universitaire vaudois (CHUV)
RECRUITING
Lausanne
Kantonsspital St.Gallen
RECRUITING
Sankt Gallen
Universitätsspital Zurich
RECRUITING
Zurich
Contact Information
Primary
Laurent Roten, PD Dr. med.
laurent.roten@insel.ch
+41 31 632 52 63
Backup
Thomas Meinel, Dr. med.
thomas.meinel@insel.ch
+41 76 49 28 545
Time Frame
Start Date: 2020-09-08
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 150
Related Therapeutic Areas
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov