Analysis of the Role of T-cell Response in Patients With Atrial Fibrillation for Clinical Application

July 15, 2018 updated by: Yonsei University
The purpose of this study is 1) to characterize T-cell response in patients with atrial fibrillation, and 2) to analyze the changes of T-cell response after radio-frequency catheter ablation of atrial fibrillation. First, immune-phenotyping and cytokine profiling of T cells from patients with atrial fibrillation will performed. Next the difference of T-cell immunity among various type of atrial fibrillation patients will be analyzed. Finally the changes of T-cell response and cytokines after radio-frequency catheter ablation of atrial fibrillation will be assessed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Cardiovascular Hospital, Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with atrial fibrillation

Description

Inclusion Criteria:

  • Patients who consent with study
  • patients with age more than19
  • patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

Exclusion Criteria:

  • Patients who do not agree with study inclusion
  • Permanent AF refractory to electrical cardioversion
  • AF with rheumatic valvular disease
  • Patients with left atrial diameter greater than 60mm
  • Patients with age less than 19
  • Patient with malignant tumor and chronic infection disease
  • Patient are given immune inhibitor and steroidal anti-inflammatory drug within 2weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
Atrial fibrillation patients
Other: radio-frequency catheter ablation of atrial fibrillation
radio-frequency catheter ablation of atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency (%) of specific marker-expressing cells among CD4 or CD8 T-subsets
Time Frame: 1 year
  • Immunosenescence marker: CD28, CD57
  • Activation marker: CD38, HLA-DR
  • Differentiation marker: CCR7, CD45RA
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency (%) of cytokine-secreting cells among CD4 or CD8 T-subsets
Time Frame: 1 year
  • Proinflammatory cytokine: IFN-gamma, TNF-alpha
  • Cytotoxic molecule: granzyme B, perforin
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 15, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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