Atrial Fibrillation in Cryptogenic Stroke and TIA (NOR-FIB)
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|ClinicalTrials.gov Identifier: NCT02937077|
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : January 25, 2022
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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.
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Ischemic Stroke TIA||Device: Medtronic Reveal LINQ|
|Study Type :||Observational|
|Actual Enrollment :||259 participants|
|Official Title:||The Nordic Atrial Fibrillation and Stroke Study|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||October 2021|
|Actual Study Completion Date :||October 2021|
- 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 ]
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Cryptogenic ischemic stroke patients or symptomatic TIA < 21 days from symptom start.
A stroke/TIA is considered to be cryptogenic if no cause can be determined despite an extensive workup according to the standard protocol of the participating center. Before inclusion to the study, the following tests are required as standard tests to establish the diagnosis of cryptogenic stroke or TIA:
- Brain MRI or CT†
- 12-lead ECG for AF detection
- 24-h ECG monitoring for AF detection and premature atrial complex analysis (e.g. Holter)
- TEE (transesophageal echocardiography) highly recommended or TTE (transthoracic echocardiography)
- Colour Duplex ultrasound examination of the pre-cerebral arteries
- CTA or MRA of head and neck to rule out other causes of stroke pathologies
- Age 18 to 80 at onset of TIA/stroke
A participation consent form signed by the patient or a legally authorized representative.
- TIA cases with acute non-lacunar infarct on Diffusion Weighted Imaging are included as TIA events.
- Known etiology of TIA or stroke.
- TIA without documented cerebral ischemia on Diffusion Weighed Imaging.
- Untreated hyperthyroidism
- Myocardial infarction less than 1 month prior to the stroke or TIA.
- Coronary bypass grafting less than 1 month prior to the stroke or TIA.
- Valvular heart disease requiring immediate surgical intervention.
- History of atrial fibrillation or atrial flutter.
- Patent Foramen Ovale (PFO) or PFO where there is or was an indication to start oral anticoagulation
- Permanent indication for OAC treatment at enrollment.
- Permanent contra-indication for OAC.
- Life expectancy less than 1 year.
- An indication for an Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system.
- Patient otherwise not eligible for the study or adherent for follow-up (e.g. non-resident) or has concurrent disease which may affect clinical outcome (e.g. multiple sclerosis, cancer).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937077
|Østfold Hospital Trust|
|Sarpsborg, Grålum, Norway, 1714|
|Oslo University Hospital|
|Oslo, Norway, 0424|
|Principal Investigator:||Anne Hege Aamodt, MD, PhD||Oslo University Hospital|
|Study Chair:||Dan Atar, MD, PhD||Oslo University Hospital|
|Responsible Party:||Anne Hege Aamodt, Dr., Oslo University Hospital|
|Other Study ID Numbers:||
|First Posted:||October 18, 2016 Key Record Dates|
|Last Update Posted:||January 25, 2022|
|Last Verified:||January 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Plan to share IPD|
Central Nervous System Diseases
Nervous System Diseases