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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03816865
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
Ostfold Hospital Trust
Information provided by (Responsible Party):
Anne Hege Aamodt, Oslo University Hospital

Study Description
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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.

Condition or disease
Atrial Fibrillation Stroke

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fibrosis, Inflammation and Brain Health in Atrial Fibrillation. The Norwegian Atrial Fibrillation and Stroke Study
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion. [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with atrial fibrillation undergoing direct-current cardioversion
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816865


Contacts
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Contact: Anne Hege Aamodt, MD, PhD +47 95867270 anhaam@ous-hf.no
Contact: Gudrun Høie, MD +47 97652459 gudrun.anette.hoie@so-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Anne Hege Aamodt, MD PhD    +4723074976    anne.hege.aamodt@ous-hf.no   
Østfold Hospital Recruiting
Sarpsborg, Norway
Contact: Peter Andel         
Sponsors and Collaborators
Oslo University Hospital
Ostfold Hospital Trust
More Information
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Responsible Party: Anne Hege Aamodt, Senior Consultant in Neurology, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03816865    
Other Study ID Numbers: NOR-FIB2
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Inflammation
Cardiovascular Diseases
 Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes