NCT00861575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,601

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

6 years

First QC Date

March 12, 2009

Last Update Submit

November 16, 2017

Conditions

Cardiovascular Disease

Keywords

Cardiovascular

Outcome Measures

Primary Outcomes (1)

  • To assess the relationship of multiple phenotypes and genotypes with cardiovascular disease

    Yearly

Secondary Outcomes (1)

  • To assess the impact of phenotypes and genotypes of specific patient subgroups (gender, ethnic, family history) on cardiovascular disease

    Yearly

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects undergoing a clinical required cardiovascular procedure

You may qualify if:

  • \> 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Sarah Rinehart, MD

    Piedmont Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

February 1, 2006

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

US(1)