Pre Procedural Biomarkers Might Predict Recurrent Atrial Fibrillation After Catheter Ablation

Tanta University

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Diagnostic Test: Measuring Serum bio-markers

Study type: Interventional

Funder types: Other

Identifiers

NCT05114772

34816/7/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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117 participants in 2 patient groups

Recurrent Atrial fibrillation

Active Comparator group

Description:

patients developed Recurrent Atrial fibrillation catheter ablation

Treatment:

Diagnostic Test: Measuring Serum bio-markers

NO Recurrent Atrial fibrillation

Active Comparator group

Description:

patients didn't develop Recurrent Atrial fibrillation catheter ablation

Treatment:

Diagnostic Test: Measuring Serum bio-markers