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Pre Procedural Biomarkers Might Predict Recurrent Atrial Fibrillation After Catheter Ablation

NCT ID: NCT05114772

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Recurrent Atrial fibrillation

patients developed Recurrent Atrial fibrillation catheter ablation

Group Type ACTIVE_COMPARATOR

Measuring Serum bio-markers

Intervention Type DIAGNOSTIC_TEST

ELISA Estimation of Serum visfatin and tumor necrosis factor-alpha

NO Recurrent Atrial fibrillation

patients didn't develop Recurrent Atrial fibrillation catheter ablation

Group Type ACTIVE_COMPARATOR

Measuring Serum bio-markers

Intervention Type DIAGNOSTIC_TEST

ELISA Estimation of Serum visfatin and tumor necrosis factor-alpha

Interventions

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Measuring Serum bio-markers

ELISA Estimation of Serum visfatin and tumor necrosis factor-alpha

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Amr Fayez Al-kassas

lecturer of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr El kassas, MD

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

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Tanta university

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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34816/7/19

Identifier Type: -

Identifier Source: org_study_id