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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVrinnevi Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Persistent atrial fibrillation (ICD-10 I48.1)

Age over 18 years

Disqualifiers

Autoimmune disease

Inflammatory diseases

Acute or chronic liver dysfunction

Ongoing infectious diseases

Trial population

The study included patients aged 18 or older diagnosed with persistent atrial fibrillation (ICD-10 I48.1) scheduled for ECV. Inclusion took place from 2023-10-18 to 2025-06-01.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sampling

    Other intervention

    Blood sampling

Treatment groups

182 Participants
are divided into 1 treatment group
Group A: Prospective cohort1 intervention

Trial outcomes

Primary outcomes

1

Recurrence of AF

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

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

Secondary outcomes

1

Fluctuations of biomarkers and gene expression during follow-up

Change in biomarker level or expression of gene expressions during follow-up.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vrinnevi Hospital

Lead sponsor

Ryhov County Hospital

Collaborator