Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation (IERV)

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

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Atrial Fibrillation; Genetic Predisposition to Disease
• Intervention / Treatment: Other: Blood sampling

• Study Type: Observational
• Enrollment (Estimated): 182

Contacts and Locations

• Study Contact: Name: Jakob Hytting, MD; Phone Number: +46 + 707679724; Email: jakob.hytting@liu.se

Study Locations

• Sweden
  • Småland
    • Jönköping, Småland, Sweden
      • Recruiting
      • Medical department
      • Contact: Jakob Hytting, MD; Email: jakob.hytting@liu.se
  • Östergötland
    • Norrköping, Östergötland, Sweden
      • Recruiting
      • Cardiology Clinic
      • Contact: Jakob Hytting, MD; Email: jakob.hytting@liu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective cohort; Prospective cohort measuring the previously described biomarkers.	Other: Blood sampling; Blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of AF	Recurrence of atrial fibrillation or atrial flutter recorded on 12-lead ECG or through pacemaker interpretation	During follow-up (post ECV, day 7, 30, 90, and 180)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluctuations of biomarkers and gene expression during follow-up	Change in biomarker level or expression of gene expressions during follow-up.	During follow-up (post ECV, day 7, 30, 90, and 180)

Collaborators and Investigators

• Sponsor: Vrinnevi Hospital
• Collaborators: Ryhov County Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Disease Susceptibility; Inflammation; Atrial Fibrillation; Genetic Predisposition to Disease
• Other Study ID Numbers: Dnr 2023-02252-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No