Background: Different studies with real-life data and randomized controlled trials have shown a detection rate of paroxysmal atrial fibrillation (AF) of 10-20% in patients with cryptogenic stroke using insertable continuous cardiac monitoring for 6 months. More studies are needed, however, to identify factors which can be used to select the patients where the possibility of detecting AF with prolonged rhythm monitoring is highest, to evaluate the best duration of rhythm monitoring, to determine the optimal definition of short-term AF that warrants intervention and to evaluate whether intervention results in improved clinical outcomes. Methods: The NOR-FIB study is a multi-centre prospective observational trial, designed to evaluate detection of AF in cryptogenic stroke and transient ischemic attack (TIA). Patients admitted with cryptogenic stroke or TIA in stroke units in the Nordic countries, aged 18-80 years are included and have the Reveal LINQ® Insertable cardiac monitor system implanted for 12 months for the purpose of AF detection. Biomarkers that may identify patients, who could derive the most clinical benefit from the detection of AF by prolonged monitoring, are being studied. Conclusion: This NOR-FIB study will increase our knowledge regarding the occurrence of AF in patients with cryptogenic stroke and TIA that potentially can improve secondary prevention. The study will provide information on biomarkers that may be used to select cryptogenic TIA and stroke patients for long-term monitoring as well as information on the significance of short-term AF and optimal duration of cardiac rhythm monitoring.
Study Type
OBSERVATIONAL
Enrollment
259
Østfold Hospital Trust
Sarpsborg, Grålum, Norway
Oslo University Hospital
Oslo, Norway
Atrial fibrillation detection rate
Time frame: within 6 months
AF detection rate
Time frame: within 12 months
Levels of miRNAs related to atrial fibrillation
Time frame: 12 months
Levels of NT-proBNP
Time frame: baseline and 12 months
Levels of Troponin-T
Time frame: baseline and 12 months
Levels of inflammation biomarkers
Time frame: baseline and 12 months
Prestroke/pre-TIA CHA2DS2-VASc score
Time frame: baseline
Incidence of recurrent stroke or TIA - percentage of stroke/TIA within 12 9. Incidence of recurrent stroke or TIA - percentage of stroke/TIA
Time frame: 12 months
Use of oral anticoagulation - percentage of patients who are using OAC drugs
Time frame: 12 months
Use of antiarrhythmic drugs - percentage of patients who are using antiarrhythmic drugs
Time frame: 12 month
Health Outcome as Evaluated by an EQ-5D Questionnaire - EQ-5D quality of life score
Time frame: 12 months
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