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

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Atrial Fibrillation

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Anne Hege Aamodt, MD, PhD; Phone Number: +47 95867270; Email: anhaam@ous-hf.no
• Study Contact Backup: Name: Gudrun Høie, MD; Phone Number: +47 97652459; Email: gudrun.anette.hoie@so-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Recruiting
    • Oslo University Hospital
  • Sarpsborg, Norway
    • Recruiting
    • Østfold Hospital
    • Contact: Peter Andel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with atrial fibrillation undergoing direct-current cardioversion

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Ostfold Hospital Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Inflammation; Atrial Fibrillation
• Other Study ID Numbers: NOR-FIB2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No