Atrial Fibrillation in Cryptogenic Stroke and TIA "NOR-FIB"

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

Trial Design

  • Observation: Case-Only
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Patients admitted to stroke units with cryptogenic ischemic stroke or TIA

Outcomes

Type Measure Time Frame Safety Issue
Primary Atrial fibrillation detection rate within 6 months No
Secondary AF detection rate within 12 months No
Secondary Levels of miRNAs related to atrial fibrillation 12 months No
Secondary Levels of NT-proBNP baseline and 12 months No
Secondary Levels of Troponin-T baseline and 12 months No
Secondary Levels of inflammation biomarkers baseline and 12 months No
Secondary Prestroke/pre-TIA CHA2DS2-VASc score baseline No
Secondary Incidence of recurrent stroke or TIA - percentage of stroke/TIA within 12 9. Incidence of recurrent stroke or TIA - percentage of stroke/TIA 12 months Yes
Secondary Use of oral anticoagulation - percentage of patients who are using OAC drugs 12 months Yes
Secondary Use of antiarrhythmic drugs - percentage of patients who are using antiarrhythmic drugs 12 month No
Secondary Health Outcome as Evaluated by an EQ-5D Questionnaire - EQ-5D quality of life score 12 months No

Biospecimen Retention:Samples With DNA - blood samples

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