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

Study acronym: IERV
StatusUnknown
PhaseNot specified
Started

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.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary endpoint revisedv2 Show 5 more changesShow less
    • Enrollment target: 205 to 182
    • Secondary endpoints expanded, about 8 words
    • Collaborator revised
    • Eligibility criteria shortened, about 1 word
    • Study title shortened, about 4 words
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06399666
Lead Sponsor Vrinnevi Hospital
Collaborators: Ryhov County Hospital
Conditions
(from sponsor)		 Atrial Fibrillation, Inflammation, Genetic Predisposition to Disease
Related terms Atrial Fibrillation, Genetic Predisposition to Disease, Inflammation
Enrollment 182 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov