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Fibrosis, Inflammation and Brain Health in Atrial Fibrillation.

NCT03816865 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2024-07-03

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Ostfold Hospital Trust

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2023-12-31
Completion
2024-03-31

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03816865 on ClinicalTrials.gov