Atrial Fibrillation in Cryptogenic Stroke and TIA

Last updated: January 9, 2022
Sponsor: Oslo University Hospital
Overall Status: Completed

Phase

N/A

Condition

Blood Clots

Chest Pain

Dysrhythmia

Treatment

N/A

Clinical Study ID

NCT02937077
2013/2371
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Cryptogenic ischemic stroke patients or symptomatic TIA < 21 days from symptom start.
  2. A stroke/TIA is considered to be cryptogenic if no cause can be determined despite anextensive workup according to the standard protocol of the participating center.Before inclusion to the study, the following tests are required as standard tests toestablish the diagnosis of cryptogenic stroke or TIA:
  3. Brain MRI or CT†
  4. 12-lead ECG for AF detection
  5. 24-h ECG monitoring for AF detection and premature atrial complex analysis (e.g.Holter)
  6. TEE (transesophageal echocardiography) highly recommended or TTE (transthoracicechocardiography)
  7. Colour Duplex ultrasound examination of the pre-cerebral arteries
  8. CTA or MRA of head and neck to rule out other causes of stroke pathologies
  9. Age 18 to 80 at onset of TIA/stroke
  10. A participation consent form signed by the patient or a legally authorizedrepresentative.
  • TIA cases with acute non-lacunar infarct on Diffusion Weighted Imaging areincluded as TIA events.

Exclusion

Exclusion Criteria:

  1. Known etiology of TIA or stroke.
  2. TIA without documented cerebral ischemia on Diffusion Weighed Imaging.
  3. Untreated hyperthyroidism
  4. Myocardial infarction less than 1 month prior to the stroke or TIA.
  5. Coronary bypass grafting less than 1 month prior to the stroke or TIA.
  6. Valvular heart disease requiring immediate surgical intervention.
  7. History of atrial fibrillation or atrial flutter.
  8. Patent Foramen Ovale (PFO) or PFO where there is or was an indication to start oralanticoagulation
  9. Permanent indication for OAC treatment at enrollment.
  10. Permanent contra-indication for OAC.
  11. Life expectancy less than 1 year.
  12. Pregnancy
  13. An indication for an Implantable Pulse Generator (IPG), ImplantableCardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or animplantable hemodynamic monitoring system.
  14. 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).

Study Design

Total Participants: 259
Study Start date:
December 01, 2016
Estimated Completion Date:
October 31, 2021

Connect with a study center

  • Østfold Hospital Trust

    Kalnes, Grålum 1714
    Norway

    Site Not Available

  • Østfold Hospital Trust

    Sarpsborg, Grålum 1714
    Norway

    Site Not Available

  • Oslo University Hospital

    Oslo, 0424
    Norway

    Site Not Available

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