Coronary Artery DiseaseiPSCNCT01517425
Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells
An observational study of Coronary Artery Disease, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
This research is being done to understand how changes in DNA may put people at risk for developing coronary artery disease. Stem cells will be made using cells from blood and/or skin biopsy samples. We are trying to understand which specific changes in DNA negatively impact a person's health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects previously enrolled in the Scripps Genebank or Healthy Elderly Active Longevity (HEAL) Cohort
Who may be able to join
- Cases:
- Previously enrolled in the CAD module of the Genebank at Scripps Clinic Registry
- Eligible to have their blood drawn
- Be reliable, cooperative and willing to comply with all protocol-specified procedures
- Able to understand and grant informed consent
- Controls:
Show all 10Show fewer
- Previously enrolled in the Healthy Elderly Active Longevity (HEAL) Cohort
- Eligible to have their blood drawn
- Be reliable, cooperative and willing to comply with all protocol-specified procedures
- Able to understand and grant informed consent
Who cannot join
- Unwilling or unable to grant informed consent.
- Have a significant medical condition that in the Investigator's opinion may interfere with subject's study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Scripps Translational Science Institute
La Jolla, California, 92037
About this study
This research is being done to understand how changes in DNA may put people at risk for developing coronary artery disease. Stem cells will be made using cells from blood and/or skin biopsy samples. We are trying to understand which specific changes in DNA negatively impact a person's health.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Subjects previously enrolled in the Scripps Genebank Study | |
| Controls | Subjects previously enrolled in the Scripps Healthy Elderly Active Longevity (HEAL) Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
iPSC development
Develop methods of iPSC generation from patients with genomic risk.
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2025 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Topol, MD, Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517425
- Sponsor's protocol ID
- 11-5676
- Acronym
- iPSC
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2012
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells
- ClinicalTrials.gov ID
- NCT01517425
- Acronym / sponsor ID
- iPSC / 11-5676
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 25 Jan 2012 (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 research is being done to understand how changes in DNA may put people at risk for developing coronary artery disease. Stem cells will be made using cells from blood and/or skin biopsy samples. We are trying to understand which specific changes in DNA negatively impact a person's health.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Subjects previously enrolled in the Scripps Genebank Study |
| Controls | – | –Subjects previously enrolled in the Scripps Healthy Elderly Active Longevity (HEAL) Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects previously enrolled in the Scripps Genebank or Healthy Elderly Active Longevity (HEAL) Cohort
Key inclusion criteria (10 listed)
- Previously enrolled in the CAD module of the Genebank at Scripps Clinic Registry
- Eligible to have their blood drawn
- Be reliable, cooperative and willing to comply with all protocol-specified procedures
- Able to understand and grant informed consent
- Previously enrolled in the Healthy Elderly Active Longevity (HEAL) Cohort
Key exclusion criteria (2 listed)
- Unwilling or unable to grant informed consent.
- Have a significant medical condition that in the Investigator's opinion may interfere with subject's study participation.
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
iPSC development
Time frame: five years
Develop methods of iPSC generation from patients with genomic risk.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Artery Disease, run by Scripps Translational Science Institute 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 10 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 16 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
iPSC development (time frame: five years). 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 16 Jan 2025.