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Completed

NCT Number: NCT02937077

Atrial Fibrillation in Cryptogenic Stroke and TIA

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Østfold Hospital Trust, Sarpsborg, Grålum, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Pregnancy
  • 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).

Treatment and study plan

Medtronic Reveal LINQ

Device

Primary outcomes

  1. Atrial fibrillation detection rate

    Time frame: within 6 months

Secondary outcomes

  1. AF detection rate

    Time frame: within 12 months

  2. Levels of miRNAs related to atrial fibrillation

    Time frame: 12 months

  3. Levels of NT-proBNP

    Time frame: baseline and 12 months

  4. Levels of Troponin-T

    Time frame: baseline and 12 months

  5. Levels of inflammation biomarkers

    Time frame: baseline and 12 months

  6. Prestroke/pre-TIA CHA2DS2-VASc score

    Time frame: baseline

  7. 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

  8. Use of oral anticoagulation - percentage of patients who are using OAC drugs

    Time frame: 12 months

  9. Use of antiarrhythmic drugs - percentage of patients who are using antiarrhythmic drugs

    Time frame: 12 month

  10. Health Outcome as Evaluated by an EQ-5D Questionnaire - EQ-5D quality of life score

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Bispebjerg Hospital
  • Diakonhjemmet Hospital
  • Drammen sykehus
  • Haukeland University Hospital
  • Helse Stavanger HF
  • Herlev Hospital
  • Molde Hospital
  • Nordlandssykehuset HF
  • Ostfold Hospital Trust
  • Rigshospitalet, Denmark
  • Skane University Hospital
  • Sykehuset Innlandet HF
  • Sykehuset Telemark
  • The Hospital of Vestfold
  • Ullevaal University Hospital
  • University Hospital of North Norway
  • Vestre Viken Hospital Trust

Registry information

Official study title

The Nordic Atrial Fibrillation and Stroke Study

Acronym: NOR-FIB

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 18, 2016
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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