Cardiogenomics Registry | NCT00861575

Studies
Cardiogenomics Registry

NCT00861575

Sponsor

Piedmont Healthcare

Status

Completed

Last Update Posted

Nov 20, 2017Actual

Enrollment

2,601Actual

Phase

Not provided

Conditions

Cardiovascular Disease

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

Nov 2017

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 2006

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Mar 12, 2009

First Submission Date that Met QC Criteria

Mar 12, 2009

First Posted Date

Mar 13, 2009Estimated

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

Nov 16, 2017

Last Update Posted Date

Nov 20, 2017Actual

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

This is a continuous blood banking study that will archive plasma and blood permitting DNA and plasma analysis at a future date. Subjects are recruited at the time of a clinically required procedure and blood samples are collected and banked and used for future research. The main purpose of this study is to investigate the interaction of multiple phenotypes and genotypes and their impact on cardiovascular disease events and measures of atherosclerosis progression.

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

2,601Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the relationship of multiple phenotypes and genotypes with cardiovascular disease		Yearly

Secondary Outcomes

Measure	Description	Time Frame
To assess the impact of phenotypes and genotypes of specific patient subgroups (gender, ethnic, family history) on cardiovascular disease		Yearly

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 17 years of age
Undergoing a clinical required cardiovascular procedure
Agree to donation of blood sample
Provide written informed consent and Authorization for Use/Disclosure of PHI

Exclusion Criteria:

< 18 years of age
Refusal to donate a blood sample
Refusal to provide written informed consent and Authorization for Use/Disclosure of PHI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects undergoing a clinical required cardiovascular procedure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah Rinehart, MD	Piedmont Healthcare	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Piedmont Hospital		Atlanta	Georgia	30309	United States

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided