Pre Procedural Biomarkers Might Predict Recurrent Atrial Fibrillation After Catheter Ablation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05114772
• Other study ID #: 34816/7/19
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: November 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• Measuring Serum bio-markers
ELISA Estimation of Serum visfatin and tumor necrosis factor-alpha

Locations

Country	Name	City	State
Egypt	Tanta university	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent Atrial Fibrillation	Recurrent Atrial Fibrillation after Catheter ablation	12 months