- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01517425
Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells (iPSC)
March 16, 2021 updated by: Eric Topol, MD, Scripps Translational Science Institute
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 Overview
Status
Enrolling by invitation
Conditions
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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La Jolla, California, United States, 92037
- Scripps Translational Science Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects previously enrolled in the Scripps Genebank or Healthy Elderly Active Longevity (HEAL) Cohort
Description
Inclusion Criteria:
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:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cases
Subjects previously enrolled in the Scripps Genebank Study
|
Controls
Subjects previously enrolled in the Scripps Healthy Elderly Active Longevity (HEAL) Cohort
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
iPSC development
Time Frame: five years
|
Develop methods of iPSC generation from patients with genomic risk.
|
five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Anticipated)
July 1, 2025
Study Completion (Anticipated)
July 1, 2030
Study Registration Dates
First Submitted
January 20, 2012
First Submitted That Met QC Criteria
January 20, 2012
First Posted (Estimate)
January 25, 2012
Study Record Updates
Last Update Posted (Actual)
March 17, 2021
Last Update Submitted That Met QC Criteria
March 16, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-5676
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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