Fibrosis, Inflammation and Brain Health in Atrial Fibrillation. (NOR-FIB2)
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|ClinicalTrials.gov Identifier: NCT03816865|
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : March 3, 2021
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).
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
• Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion.
- 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.
|Condition or disease|
|Atrial Fibrillation Stroke|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Fibrosis, Inflammation and Brain Health in Atrial Fibrillation. The Norwegian Atrial Fibrillation and Stroke Study|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
- Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion. [ Time Frame: 2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816865
|Contact: Anne Hege Aamodt, MD, PhD||+47 email@example.com|
|Contact: Gudrun Høie, MD||+47 firstname.lastname@example.org|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, 0424|
|Contact: Anne Hege Aamodt, MD PhD +4723074976 email@example.com|
|Contact: Peter Andel|