Analysis of the Role of T-cell Response in Patients With... | NCT02421900

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

NCT02421900

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Jul 17, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

radio-frequency catheter ablation of atrial fibrillation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2015Actual

Primary Completion Date

Mar 2020Estimated

Completion Date

Mar 2020Estimated

First Submitted Date

Apr 8, 2015

First Submission Date that Met QC Criteria

Apr 15, 2015

First Posted Date

Apr 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2018

Last Update Posted Date

Jul 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1		Atrial fibrillation patients	Other: radio-frequency catheter ablation of atrial fibrillation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radio-frequency catheter ablation of atrial fibrillation	Other	radio-frequency catheter ablation of atrial fibrillation	group 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with atrial fibrillation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hui-Nam Pak, MD, PhD	Contact	82-2-2228-8459		hnpak@yuhs.ac

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Cardiovascular Hospital, Yonsei University Health System	Recruiting	Seoul		120-752	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided