- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02421900
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
-
-
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Seoul, Korea, Republic of, 120-752
- Recruiting
- Severance Cardiovascular Hospital, Yonsei University Health System
-
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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
|
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
|
|
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
|
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.