Fibrosis, Inflammation and Brain Health in Atrial Fibrillation.
NCT ID: NCT03816865
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
46 participants
OBSERVATIONAL
2018-03-01
2024-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Exclusion Criteria
2. Life expectancy less than 1 year
3. Patient otherwise not eligible for the study or adherent for follow-up (eg nonresident) or has concurrent disease affecting outcome (e.g. multiple sclerosis, cancer)
18 Years
80 Years
ALL
No
Sponsors
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Ostfold Hospital Trust
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Anne Hege Aamodt
Senior Consultant in Neurology
Locations
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Oslo University Hospital
Oslo, , Norway
Østfold Hospital
Sarpsborg, , Norway
Countries
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Other Identifiers
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NOR-FIB2
Identifier Type: -
Identifier Source: org_study_id
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