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Pre Procedural Biomarkers Might Predict Recurrent Atrial Fibrillation After Catheter Ablation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Measuring Serum bio-markers
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tanta university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Recurrent Atrial fibrillation

NO Recurrent Atrial fibrillation

Arm Description

patients developed Recurrent Atrial fibrillation catheter ablation

patients didn't develop Recurrent Atrial fibrillation catheter ablation

Outcomes

Primary Outcome Measures

Recurrent Atrial Fibrillation
Recurrent Atrial Fibrillation after Catheter ablation

Secondary Outcome Measures

Full Information

First Posted
October 1, 2021
Last Updated
November 5, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05114772
Brief Title
Pre Procedural Biomarkers Might Predict Recurrent Atrial Fibrillation After Catheter Ablation
Official Title
Pre Procedural High Serum Visfatin and Tumor Necrosis Factors "Alpha" Might Predict Recurrent Atrial Fibrillation After Catheter Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recurrent Atrial fibrillation
Arm Type
Active Comparator
Arm Description
patients developed Recurrent Atrial fibrillation catheter ablation
Arm Title
NO Recurrent Atrial fibrillation
Arm Type
Active Comparator
Arm Description
patients didn't develop Recurrent Atrial fibrillation catheter ablation
Intervention Type
Diagnostic Test
Intervention Name(s)
Measuring Serum bio-markers
Intervention Description
ELISA Estimation of Serum visfatin and tumor necrosis factor-alpha
Primary Outcome Measure Information:
Title
Recurrent Atrial Fibrillation
Description
Recurrent Atrial Fibrillation after Catheter ablation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr El kassas, MD
Organizational Affiliation
Faculty of medicine Tanta university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta university
City
Tanta
Country
Egypt

12. IPD Sharing Statement

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Pre Procedural Biomarkers Might Predict Recurrent Atrial Fibrillation After Catheter Ablation

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