Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age
≥ 65 years
NT-proBNP >400 pg/mL
Left atrial ventricular index >42 ml/m2 or left atrial diameter >46 mm
Disqualifiers
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)
Trial population
≥ 50 years
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Cumulative incidence of Arterial Fibrillation (AF) diagnosis over a median of 24 months
Only adjudicated events will be used for the analysis. An AF episode is defined as lasting more than 30 seconds. A diagnosis of atrial flutter will also be considered as a primary endpoint.
Time frame
From day 0 to 24 months after inclusionSecondary outcomes
1
Time to first diagnosis of AF (lasting ≥30 seconds; ≥6 minutes; ≥1 hour; ≥ 24 hour)
Time frame
From day 0 to 24 months after inclusion2
Burden of AF
The burden of AF is defined as the amount of time (percentage) in AF during rhythm monitoring. AF burden will be calculated on a monthly basis.
Time frame
From day 0 to 24 months after inclusion3
Time to composite of first diagnosis of AF, stroke and death.
Time frame
From day 0 to 24 months after inclusion4
Incidence of AF diagnosis according to Silent Brain Infarction (SBI) neuroradiological appearance (subcortical small vessel versus embolic pattern involving grey matter) and SBI fulfilling ESUS criteria versus lacunar type.
Embolic stroke of undetermined source (ESUS)
Time frame
From day 0 to 24 months after inclusionOther outcomes
1
Time to first diagnosis of AF (lasting ≥30 seconds; ≥6 minutes; ≥1 hour; ≥ 24 hours) until battery depletion of Implantable Cardiac Monitor (ICM) (36-42 month).
Time frame
From day 0 until battery depletion, expected to be 36 to 42 months2
Cumulative incidence of AF diagnosis until battery depletion of ICM
Time frame
From day 0 to until battery depletion, expected to be 36 to 42 monthsSponsors and contacts
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Source ClinicalTrials.gov