Fibrosis, Inflammation and Brain Health in Atrial Fibrillation.

Brief summary (registry, in English)

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.

What you commit to

• Study type: Observational
• Participants enrolled: 46
• From 1 Mar 2018 to the primary completion date, 31 Dec 2023
• 2 sites in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age in the registry: 18 years to 80 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.