Fibrosis, Inflammation and Brain Health in Atrial Fibrillation.

Stroke Clinical Trial

— NOR-FIB2  

Official title:

Fibrosis, Inflammation and Brain Health in Atrial Fibrillation. The Norwegian Atrial Fibrillation and Stroke Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03816865
• Other study ID #: NOR-FIB2
• Status: Recruiting
• Start date: March 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2020
• Source: Oslo University Hospital
• Contact: Anne Hege Aamodt, MD, PhD
• Phone: +47 95867270
• Email: anhaam[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Inflammation
• Stroke

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo
Norway	Østfold Hospital	Sarpsborg

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

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