Fibrosis, inflammation and cerebral infarction in patients with atrial fibrillation - (The Norwegian Atrial Fibrillation and Stroke Study - NOR-FIB 2)

Sponsor: Oslo University Hospital

Protocol number: REK 2016/133

Sponsor: Oslo University Hospital and Østfold Hospital Trust

Study Design: The study is an observational prospective study of atrial fibrillation patients undergoing direct-current cardioversion. Protocol number: REK2013/2371

Primary Objective: To assess the prevalence and causes of new silent cerebral ischemic lesions after programmed direct-current cardioversion using diffusion-weighted sequences in brain MRI (DWMRI) and dual frequency transcranial Doppler.

Secondary Objectives:

  • To study the impact of inflammation measured by biomarkers and cardiac 18F-FDG-PET on the risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF.
  • To assess the impact of fibrosis measured by biomarkers on the risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF.
  • To assess cognitive and cerebral structural and metabolic changes after direct-current cardioversion for AF using cognitive assessments and cerebral and cardiac 18F-FDG-PET before and 12 months after treatment.

Number of Subjects: 70

Duration of Study: participation 18 months, follow-up period 12 months, total study duration 30 months

Study Centers:

  • Oslo University Hospital
  • Østfold Hospital Trust

Primary Endpoints:

  • Number of new small cerebral infarcts detected with DWMRI.

 

Secondary Endpoints:

  • Rate of AF recurrence
  • Degree of cardiac fibrosis
  • Level of inflammation biomarkers 
  • Level of fibrosis biomarkers
  • Cognitive function
  • Changes in uptake pattern on cerebral 18F-FDG-PET

 

 
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