Identification of Genetic, Biochemical and Hormonal Facto... | NCT00599118

Studies
Identification of Genetic, Biochemical and Hormonal Factors Contributing to Atrial Fibrillation

NCT00599118

Sponsor

The Cleveland Clinic

Status

Active, not recruiting

Last Update Posted

Sep 10, 2025Actual

Enrollment

1,300Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

United States

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

Aug 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005Actual

Primary Completion Date

Dec 2035Estimated

Completion Date

Dec 2035Estimated

First Submitted Date

Jan 10, 2008

First Submission Date that Met QC Criteria

Jan 11, 2008

First Posted Date

Jan 23, 2008Estimated

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

Sep 8, 2025

Last Update Posted Date

Sep 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to establish a genebank repository of blood samples and data to generate information about the hereditary (genetic) basis of atrial fibrillation.

Detailed Description

Blood samples and data will be collected from subjects with atrial fibrillation and normal controls. The primary aim of future research using these samples is to identify mechanisms and pathogenesis of atrial fibrillation. Through this information, we hope to identify targets for new therapies and improve knowledge and understanding of atrial fibrillation. Identification of disease genes could improve strategies that prevent progression of atrial fibrillation to more persistent disease.

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

1,300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
atrial fibrillation		Atrial fibrillation
Control		Control subjects with no atrial fibrillation

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genetic variants associated with atrial fibrillation	Genome-wide association study of atrial fibrillation	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria for Atrial Fibrillation group:

Male or female at least 18 years old
Subjects with a history of or current Atrial Fibrillation
Subjects able to give informed consent Exclusion Criteria for Atrial Fibrillation group: no history of atrial fibrillation

Inclusion Criteria for Controls:

Male or female at least 18 years old
Subjects with no history of Atrial Fibrillation
Subjects able to give informed consent Exclusion Criteria for controls: History of atrial fibrillation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with atrial fibrillation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mina K Chung, MD	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinical Foundation		Cleveland	Ohio	44145	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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