Biochemical Marker to Predict the Recurrence of Atrial Fi... | NCT00542659

Studies
Biochemical Marker to Predict the Recurrence of Atrial Fibrillation After Surgical Maze Procedure

NCT00542659

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Jul 25, 2011Estimated

Enrollment

86Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

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 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Feb 2008Actual

First Submitted Date

Oct 10, 2007

First Submission Date that Met QC Criteria

Oct 10, 2007

First Posted Date

Oct 11, 2007Estimated

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 22, 2011

Last Update Posted Date

Jul 25, 2011Estimated

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 role of plasma NT-proBNP, hsCRP, TIMP-1(Tissue inhibitors of MetalloProteinase-1),TGF-b, MMP-3(Matrix MetalloProteinase-3), and pro-MMP-1 in predicting the recurrence of AF after surgical Maze procedure.

The association of expression of CTGF, TGF-b, BNP, ANP, collagen-1, and collagen-3 in LA with the recurrence of AF after surgical Maze procedure.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

86Estimated

Measure	Description	Time Frame
AF recurrence		year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients who have valvular heart disease with atrial fibrillation and are scheduled for operation

Exclusion Criteria:

Coronary heart disease
Congestive heart failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

The patients who have valvular heart disease with atrial fibrillation and are scheduled for operation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Young Keun On, MD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135-710	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