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Clinical Trials/NCT06399666
NCT06399666RecruitingNot Applicable

Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation

Vrinnevi Hospital2 sites in 1 country205 target enrollmentStarted: October 30, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
205
Locations
2
Primary Endpoint
Recurrence of AF

Study Overview

Brief Summary

Because of the high recurrence rates following electrical cardioversion and high morbidity in AF patients there is a need to explore prediction models for AF recurrence following ECV. Previous studies have primarily focused on high-sensitivity CRP (hsCRP), CRP, and IL-6, while other inflammatory indexes and gene scores might hold greater value.

This prospective cohort study is planning to include 205 patients with persistent atrial fibrillation, planned for electrical cardioversion, and >18 years at two medium-sized hospitals in Sweden. Blood samples will be collected prior to electrical cardioversion and at 7-, 30-, 90-, and 180-days follow-up. Atrial fibrillation recurrence will be evaluated at follow-up or upon patient request and diagnosed with 12-lead ECG.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •persistent atrial fibrillation (ICD-10 I48.1), age over 18 years

Exclusion Criteria

  • •autoimmune diseases, inflammatory diseases, acute or chronic liver dysfunction, ongoing infectious diseases, thyroid disorders, or any other conditions known to impact inflammatory activity (including medication use and hematological diseases)

Outcomes

Primary Outcomes

Recurrence of AF

Time Frame: During follow-up (post ECV, day 7, 30, 90, and 180)

Recurrence of atrial fibrillation or atrial flutter recorded on 12-lead ECG or through pacemaker interpretation

Secondary Outcomes

  • Fluctuations of biomarkers and gene expression during follow-up(During follow-up (post ECV, day 7, 30, 90, and 180))

Investigators

Sponsor
Vrinnevi Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jakob Hytting

MD

Vrinnevi Hospital

Study Sites (2)

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