The Nordic Atrial Fibrillation and Stroke Study (NOR-FIB1)

The Nordic Atrial Fibrillation and Stroke Study
(NOR-FIB1
)

Sponsor: Oslo University Hospital

Protocol number: REK2013/2371

ClinicalTrials.gov Identifier: NCT02937077

Study design:

International multi-center prospective observational study of the occurrence of AF in patients with cryptogenic stroke / TIA. Patients will be monitored with implantable cardiac monitors (ICMs) for   12 months and blood samples measuring biomarkers in the acute phase and at 12 months follow-up.

Objective:

To assess the incidence of AF detection using ICM (Reveal LINQ®) in patients with cryptogenic stroke or TIA.

To identify biomarkers that can be used as predictors of incident AF.

Number of subjects: 500

Number of centers: Up to 30

Duration of study participation:

Enrollment: approximately 18 months.

Follow-up period: 12 months ± 20 days.

Total study duration: 30 months.

Primary endpoint:
AF detection rate within 12 months.

 

Secondary endpoint

  1. AF detection rate within 6 months.
  2. Levels of NT-proBNP and BNP.
  3. Levels of Troponin-T and Troponin-I.
  4. Levels of cardiovascular biomarkers.
  5. CHA2DS2-VASc score prior to stroke or TIA.
  6. Incidence of recurrent stroke or TIA within 12 months.
  7. Use and type of oral anticoagulation - percentage of patients who are using OAC drugs at the 12-month follow-up visit.
  8. Use of antiarrhythmic drugs - percentage of patients who are using antiarrhythmic drugs at the 12-month follow-up visit.
  9. Health Outcome as Evaluated by an EQ-5D Questionnaire - EQ-5D quality of life score, which is a continuous measure of quality of life. life score, which is a continuo

 

 
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