Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells (iPSC)
This study is currently recruiting participants.
Verified December 2012 by Scripps Translational Science Institute
Sponsor:
Scripps Translational Science Institute
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01517425
First received: January 20, 2012
Last updated: December 11, 2012
Last verified: December 2012
| Tracking Information | |||||
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| First Received Date ICMJE | January 20, 2012 | ||||
| Last Updated Date | December 11, 2012 | ||||
| Start Date ICMJE | November 2012 | ||||
| Estimated Primary Completion Date | February 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
iPSC development [ Time Frame: five years ] [ Designated as safety issue: No ] Develop methods of iPSC generation from patients with genomic risk. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01517425 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells | ||||
| Official Title ICMJE | Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Subjects previously enrolled in the Scripps Genebank or Healthy Elderly Active Longevity (HEAL) Cohort |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | February 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Cases:
Controls:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01517425 | ||||
| Other Study ID Numbers ICMJE | 11-5676 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Eric Topol, MD, Scripps Translational Science Institute | ||||
| Study Sponsor ICMJE | Scripps Translational Science Institute | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Scripps Translational Science Institute | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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