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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03816865

Acronym

NOR-FIB2

Enrollment

Registered

2019-01-25

Start date

2018-03-01

Completion date

2024-03-31

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Inclusion criteria

1. Known atrial fibrillation 2. Age \<80 years 3. CHA2DS2-VASc ≤ 4 4. Planned direct-current cardioversion

Exclusion criteria

1. CHA2DS2-VASc \>4 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)

Design outcomes

Primary

Measure	Time frame
Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion.	2 weeks

Countries

Norway

Outcome results