An observational study in Cryptogenic Stroke, Atrial Fibrillation and Implantable Cardiac Monitor, sponsored by University Hospital, Akershus. Active, not recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by University Hospital, Akershus · Observational
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:
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:
Secondary objectives:
40 studies on the registry are indexed under Embolic Stroke; 11 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 364 across 27 observational studies indexed under Embolic Stroke.
Browse Embolic Stroke studies →University Hospital, Akershus is the lead sponsor of 125 studies on the registry; 28 are open to participants now.
Compared within Embolic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Ischemic Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
In total 1050 patients. A cohort of at least 700 patients of both sexes diagnosed with acute cryptogenic stroke or TIA and with an implantable cardiac monitor, admitted to the stroke unit at Akershus University Hospital, Norway.
A control group of 350 women with acute cryptogenic stroke or TIA, with non-invasive standard monitoring, admitted to the stroke unit at Haukeland University Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cryptogenic stroke/ESUS with insertable cardiac monitor for detection of atrial fibrillation
Non- invasive monitoring and standard of care. Women with cryptogenic stroke(ESUS) from another hospital
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
Plan to share: No — Due to Norwegian regulations, the data cannot be shared publicly, and the authors are not permitted to share the data or study materials used in this study. De-identified datasets may be made available from the corresponding author upon reasonable request and with appropriate ethical and institutional approvals.
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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