Cardiogenomics Registry (CGR)

This study has suspended participant recruitment.
(Staffing resources currently being restructured)
Sponsor:
Information provided by (Responsible Party):
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT00861575
First received: March 12, 2009
Last updated: September 4, 2013
Last verified: August 2013
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

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: December 2020
Estimated Primary Completion Date: December 2020 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Piedmont Healthcare
Investigators
Principal Investigator: Sarah Rinehart, MD Piedmont Healthcare
  More Information

No publications provided

Responsible Party: Piedmont Healthcare
ClinicalTrials.gov Identifier: NCT00861575     History of Changes
Other Study ID Numbers: PH05005
Study First Received: March 12, 2009
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Piedmont Healthcare:
Cardiovascular

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 15, 2014