Atrial FibrillationNOR-FIB2NCT03816865
Fibrosis, Inflammation and Brain Health in Atrial Fibrillation.
An observational study of Atrial Fibrillation and Stroke, run by Oslo University Hospital at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Stroke
- How many people
- 46 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Mar 2018to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with atrial fibrillation undergoing direct-current cardioversion
Who may be able to join
None listed.
Who cannot join
- CHA2DS2-VASc >4
- Life expectancy less than 1 year
- 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)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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).
Read more
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.
- Conditions
- Atrial Fibrillation, Stroke
- Medical subject headings
- Atrial Fibrillation, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Mar 2018
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ostfold Hospital Trust
- Responsible party
- Principal investigator, Anne Hege Aamodt, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816865
- Sponsor's protocol ID
- NOR-FIB2
- Acronym
- NOR-FIB2
- Status last verified
- Jul 2024
- First submitted
- 23 Jan 2019
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrosis, Inflammation and Brain Health in Atrial Fibrillation. The Norwegian Atrial Fibrillation and Stroke Study
- ClinicalTrials.gov ID
- NCT03816865
- Acronym / sponsor ID
- NOR-FIB2 / NOR-FIB2
- Conditions
- Atrial Fibrillation, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Ostfold Hospital Trust
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation undergoing direct-current cardioversion
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- CHA2DS2-VASc >4
- Life expectancy less than 1 year
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion.
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.