Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05114772
Other study ID # 34816/7/19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A