Cardiogenomics Registry - Full Text View

Sponsored by:	Piedmont Healthcare
Information provided by:	Piedmont Healthcare
ClinicalTrials.gov Identifier:	NCT00861575

Purpose

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.

Condition
Cardiovascular Disease

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	CAD Genotype and Phenotype Cardiac Catheterization Laboratory Registry

Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:

To assess the relationship of multiple phenotypes and genotypes with cardiovascular disease [ Time Frame: Yearly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the impact of phenotypes and genotypes of specific patient subgroups (gender, ethnic, family history) on cardiovascular disease [ Time Frame: Yearly ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

20 mL of blood are collected and aliquots of whole blood, plasma, serum and buffy coat are stored.

Estimated Enrollment:	10000
Study Start Date:	February 2006
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects undergoing a clinical required cardiovascular procedure

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861575

Contacts

Contact: Szilard Voros, MD	404-605-4905	szilard.voros@piedmont.org
Contact: Nancy Flockhart	404-605-2875	nancy.flockhart@piedmont.org

Locations

United States, Georgia
Piedmont Hospital	Recruiting
Atlanta, Georgia, United States, 30309
Contact: Szilard Voros, MD 404-605-4905 szilard.voros@piedmont.org
Contact: Nancy Flockhart 404-605-2875 nancy.flockhart@piedmont.org
Principal Investigator: Szilard Voros, MD

Sponsors and Collaborators

Piedmont Healthcare

Investigators

Principal Investigator:

Szilard Voros, MD

Piedmont Healthcare

More Information

No publications provided

Responsible Party:	Piedmont Healthcare ( Szilard Voros, MD )
Study ID Numbers:	PH05005
Study First Received:	March 12, 2009
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00861575 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Piedmont Healthcare:

Cardiovascular

Study placed in the following topic categories:

Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009