NCT03816865

Fibrosis, Inflammation and Brain Health in Atrial Fibrillation.

Fibrosis, Inflammation and Brain Health in Atrial Fibrillation. The Norwegian Atrial Fibrillation and Stroke Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

Protocol synopsis Sponsor: Oslo University Hospital Title: Fibrosis, inflammation and cerebral infarction in patients with atrial fibrillation Study Design: The study is an observational prospective study of atrial fibrillation patients undergoing direct-current cardioversion. 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). 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: 50 Study Centers: Østfold Hospital Trust Duration of Study Participation: * Enrollment: 18 months * Follow-up period: 12 months * Total Study Duration: 30 months Primary Endpoints: • Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion. Secondary Endpoints: * Rate of AF recurrence within 1 year after direct current cardioversion * Change in levels of inflammation biomarkersfrom baseline to 12 months follow-up * Change in levels of fibrosis biomarkers from baseline to 12 months follow-up * Cognitive function at 12 months follow-up * Changes in uptake pattern on cerebral 18F-FDG-PET from baseline to 12 months follow-up * Changes in uptake pattern on cardiac 18F-FDG-PET from baseline to 12 months follow-up * Brain volume at 12 months follow-up * White matter volume 12 months follow-up * Grey matter volume 12 months follow-up * Cortical volume 12 months follow-up * RSI-derived diffusion parameters 12 months follow-up: fast apparent diffusion coefficient, extracellular water fraction, fractional anisotropy; free water fraction; intracranial volume; NAWM: normal appearing white matter; neurite density; RSI: restriction spectrum imaging; sADC: slow apparent diffusion coefficient;restricted fractional anisotropy; white matter lesions.

Conditions

• Atrial Fibrillation
• Stroke

Timeline

• Start date: 2018-03-01
• Primary completion: 2023-12-31
• Completion: 2024-03-31
• First posted: 2019-01-25
• Last updated: 2024-07-03

Locations

2 sites across 1 country: Norway