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Recruiting NCT06399666

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

— Observational Atrial Fibrillation Inflammation Genetic Predisposition to Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sampling.
Who it may be relevant to
Registry conditions: Atrial Fibrillation, Inflammation, Genetic Predisposition to Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation - IERV Trial

Overview

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.

Interventions

  • Other Blood sampling
    Blood sampling

Primary outcome measures

  • Recurrence of AF [Time frame: During follow-up (post ECV, day 7, 30, 90, and 180)]
Secondary outcome measures (1)
  • Fluctuations of biomarkers and gene expression during follow-up [Time frame: During follow-up (post ECV, day 7, 30, 90, and 180)]

Eligibility criteria

Inclusion criteria

  • Persistent atrial fibrillation (ICD-10 I48.1)
  • Age over 18 years

Exclusion criteria

  • Autoimmune disease
  • Inflammatory diseases
  • Acute or chronic liver dysfunction
  • Ongoing infectious diseases
  • Thyroid disorders
  • Any other conditions known to impact inflammatory activity (including medication use and hematological diseases)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Sweden · 2 centers
  • Medical department — Jönköping
  • Cardiology Clinic — Norrköping

Identifiers

NCT: NCT06399666 · Dnr 2023-02252-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗