Cardiovascular DiseaseCGRNCT00861575
Cardiogenomics Registry
An observational study of Cardiovascular Disease, run by Piedmont Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 2,601 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing a clinical required cardiovascular procedure
Who may be able to join
- > 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
Who cannot join
- < 18 years of age
- Refusal to donate a blood sample
- Refusal to provide written informed consent and Authorization for Use/Disclosure of PHI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CAD Genotype and Phenotype Cardiac Catheterization Laboratory Registry
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.
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the relationship of multiple phenotypes and genotypes with cardiovascular disease
Measured: Yearly
Secondary outcomes (1)
To assess the impact of phenotypes and genotypes of specific patient subgroups (gender, ethnic, family history) on cardiovascular disease
Measured: Yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startFeb 2006
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piedmont Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Rinehart, MD, Principal investigator, Piedmont Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861575
- Sponsor's protocol ID
- PH05005
- Acronym
- CGR
- Status last verified
- Nov 2017
- First submitted
- 12 Mar 2009
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAD Genotype and Phenotype Cardiac Catheterization Laboratory Registry
- ClinicalTrials.gov ID
- NCT00861575
- Acronym / sponsor ID
- CGR / PH05005
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,601 participants (actual)
- Lead sponsor
- Piedmont HealthcareUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing a clinical required cardiovascular procedure
Key inclusion criteria (4 listed)
- > 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
Key exclusion criteria (3 listed)
- < 18 years of age
- Refusal to donate a blood sample
- Refusal to provide written informed consent and Authorization for Use/Disclosure of PHI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the relationship of multiple phenotypes and genotypes with cardiovascular disease
Time frame: Yearly
1 secondary outcome
To assess the impact of phenotypes and genotypes of specific patient subgroups (gender, ethnic, family history) on cardiovascular disease
Time frame: Yearly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Rinehart, MD principal investigator
Piedmont Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Piedmont Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the relationship of multiple phenotypes and genotypes with cardiovascular disease (time frame: Yearly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.