Clinical Trial

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

Study acronym: IERV
Recruiting
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Record status
This record was last updated September 19, 2024 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.
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 182 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. An interim analysis will be conducted after more than 80 patients have been included. If the results from univariate and/or multivariable logistic regression on inflammatory markers and genetic expression regarding atrial fibrillation recurrence are significant, the study will be concluded.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-04-30.
Trial Details
NCT Number NCT06399666
Lead Sponsor Vrinnevi Hospital
Collaborators: Ryhov County Hospital
Conditions Atrial Fibrillation, Inflammation, Genetic Predisposition to Disease
Enrollment 182 participants
Start Date 2023-10-30
Primary Completion 2025-06-01 (estimated)
Study Completion 2026-02-28 (estimated)
Updated on ClinicalTrials.gov 2024-09-19