The goal of this observational study is to investigate sex - differences in detection rate of atrial fibrillation after cryptogenic stroke (embolic stroke of unknown cause) - using an implantable cardiac rhythm monitor - and the treatment effects of oral anticoagulation on recurrent stroke, ischemic cardiovascular events, major bleeding risk, disability and mortality. The main questions to answer are: * Is long-term monitoring and detection of atrial fibrillation after stroke of unknown cause in women related to recurrent stroke and disability? * Is long-term monitoring and initiation of oral anticoagulation related to cardiovascular events and intracranial haemorrhages? And in addition increased in women compared to men? * Is long-term rhythm monitoring after stroke with unknown cause related to patient reported outcomes in women?
This is a prospective, observational, study including consecutive patiens with acute cryptogenic stroke /embolic stroke of unknown source (ESUS) or transient ischemic attack (TIA) admitted between 2016 and 2023 at Akershus University Hospital (AUH). As part of the standard investigation at AUH, selected patients are offered an implantable cardiac monitor (ICM) and followed up for detection of atrial fibrillation (AF) by a specialised neurocardiology team. A control group recruited at another hospital during the same period, Haukeland University Hospital (HUS), only comprise women. The primary objectives: * To investigate among women with stroke of unknown cause, the effect of implantable cardiac monitors compared to standard non-invasive approach on AF detection, recurrent stroke, death and disability. * To investigate sex- differences in patients with stroke of unknown cause, the effect of implantable cardiac monitors on AF detection, recurrent stroke, death and disability. Secondary objectives: * To compare the rate of cardiovascular events and intracranial haemorrhages after stroke of unknown cause in women offered implantable cardiac monitors, compared to best standard non-invasive follow up * To investigate the impact of implantable cardiac monitors on the use of oral anticoagulation in women * To investigate self-perceived health and health related quality of life after stroke of unknown cause in women offered implantable loop recorders, compared to women offered best standard non-invasive approach to detect AF
Study Type
OBSERVATIONAL
Enrollment
1,400
Akershus University Hospital, Department of Neurology
Oslo, Lørenskog/Akershus, Norway
Atrial fibrillation deteceted after stroke and transient ischemic attack (TIA)
\>30 seconds of atrial fibrillation detection using implantable cardiac monitor/implantable loop-recorder
Time frame: 30 days and 1 year after index stroke
Recurrent ischemic stroke after 1 and 2 years
Ischemic stroke/TIA: Clinical diagnosis (TOAST criteria) verified by CT and/or MR.
Time frame: 30 days, 1 and 2 years after index stroke
Composite of stroke and mortality
Ischemic and heamorragic stroke, (ICD-10 I63 and I61) transient ischemic attack(TIA) (ICD10: G45.9) and mortality
Time frame: 30 days, 1 and 2 years after index stroke
Intracranial bleeding
Symptomatic intracranial heamorrage (stroke) (ICD-10: I61)
Time frame: 30 days, 1 and 2 years after index stroke
Patient Reported Outcome Measureres
Self-perceived health and health related quality of life by using the EuroQol scale (EQ-5D-5L)
Time frame: 3 months after index stroke
Ischemic cardiac events
Hospitaized for ischemic cardiac events (ICD10 20-25)
Time frame: 1 and 2 years
Safety outcome
Hospitalized for gastrointestinal bleeding (ICD 10 K92) and/or intracranial bleeding (I61)
Time frame: 1 and 2 years after index stroke
Oral anticoagulation
Use of oral anticoagulation
Time frame: 1 and 2 years
Functional outcome 3 months post-stroke
Functional outcome 3 months post-stroke using modified Rankin Scale (mRS) from the national stroke registry
Time frame: 3 months after index stroke
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