Pre Procedural Biomarkers Might Predict Recurrent Atrial Fibrillation After Catheter Ablation

Pre Procedural High Serum Visfatin and Tumor Necrosis Factors "Alpha" Might Predict Recurrent Atrial Fibrillation After Catheter Ablation

Evaluation of the predictive value of serum levels of adipocytokines and primary phase reactant for recurrent atrial fibrillation (RAF) after catheter ablation in 26 patients had persistent and 91 patients had paroxysmal AF. During 12-m follow-up, 41 patients had RAF (35%). Patients had RAF were significantly older, had significantly higher BMI, lower ejection fraction and wider maximal left atrial diameter (LAD). Serum hs-CRP, IL-6, TNF-α, visfatin, and adiponectin levels were significantly higher in patients developed. Elevated serum levels of TNF-α, visfatin and adiponectin are a significant positive predictors for RAF.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: Measuring Serum bio-markers

Detailed Description

Objectives: Estimation of serum levels of visfatin, adiponectin, tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) in patients had atrial fibrillation (AF) resistant to medical treatment and assigned to catheter ablation (CA) to evaluate these biomarkers as predictors for recurrent AF (RAF).

Patients & Methods: 117 patients; 26 patients had persistent and 91 patients had paroxysmal AF underwent had clinical and echographic evaluations and gave blood samples for ELISA estimation of serum levels of studied cytokines. CA was performed through isolation of all pulmonary veins according to the stepwise procedure of ablation. Patients were re-evaluated every three months till 12-m follow-up for post-procedural RAF.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Symptomatic paroxysmal or persistent AF that was resistant to medical acceptable daily dose therapy in patients who were free of exclusion criteria and accepted to sign the written fully informed consent to undergo CA and to give pre-procedural blood samples.

Exclusion Criteria:

• History of the presence of longstanding persistent or permanent AF,
• myocardial infarction, acute coronary syndrome (ACS),
• significant heart failure (NYHA3),
• dilated or hypertrophic cardiomyopathy,
• left ventricular ejection fraction (LVEF)< 35%, congenital pathologies,
• significant valvular heart disease,
• pulmonary embolism,
• venous thrombosis,
• intracardiac thrombus or inability to take warfarin or other oral anticoagulants,
• hepatic or renal insufficiency,
• acute inflammatory states (sepsis, chronic obstructive pulmonary disease in acute phase),
• cancer,
• autoimmune pathologies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Recurrent Atrial fibrillation; patients developed Recurrent Atrial fibrillation catheter ablation	Diagnostic test: Measuring Serum bio-markers; ELISA Estimation of Serum visfatin and tumor necrosis factor-alpha
Active Comparator: NO Recurrent Atrial fibrillation; patients didn't develop Recurrent Atrial fibrillation catheter ablation	Diagnostic test: Measuring Serum bio-markers; ELISA Estimation of Serum visfatin and tumor necrosis factor-alpha

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent Atrial Fibrillation	Recurrent Atrial Fibrillation after Catheter ablation	12 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Amr El kassas, MD, Faculty of Medicine Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 34816/7/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No