Stroke Clinical Trial - Fibrosis, Inflammation & Brain Health in Atrial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

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Clinical Trial Details

NCT number	NCT03816865
Study type	Observational
Source	Oslo University Hospital
Contact	Anne Hege Aamodt, MD, PhD
Phone	+47 95867270
Email	anhaam@ous-hf.no
Status	Recruiting
Phase
Start date	March 1, 2018
Completion date	December 31, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Fibrosis, Inflammation and Brain Health in Atrial Fibrillation. — NOR-FIB2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms