NCT05114772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

October 1, 2021

Last Update Submit

November 5, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recurrent Atrial Fibrillation

    Recurrent Atrial Fibrillation after Catheter ablation

    12 months

Study Arms (2)

Recurrent Atrial fibrillation

ACTIVE COMPARATOR

patients developed Recurrent Atrial fibrillation catheter ablation

Diagnostic Test: Measuring Serum bio-markers

NO Recurrent Atrial fibrillation

ACTIVE COMPARATOR

patients didn't develop Recurrent Atrial fibrillation catheter ablation

Diagnostic Test: Measuring Serum bio-markers

Interventions

ELISA Estimation of Serum visfatin and tumor necrosis factor-alpha

NO Recurrent Atrial fibrillationRecurrent Atrial fibrillation

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university

Tanta, Egypt

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amr El kassas, MD

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Cardiology

Study Record Dates

First Submitted

October 1, 2021

First Posted

November 10, 2021

Study Start

July 1, 2019

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

November 10, 2021

Record last verified: 2021-11

Locations