Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells (iPSC)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01517425
First received: January 20, 2012
Last updated: April 4, 2014
Last verified: April 2014

January 20, 2012
April 4, 2014
November 2012
July 2015   (final data collection date for primary outcome measure)
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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Complete list of historical versions of study NCT01517425 on ClinicalTrials.gov Archive Site
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Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells
Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells

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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Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Non-Probability Sample

Subjects previously enrolled in the Scripps Genebank or Healthy Elderly Active Longevity (HEAL) Cohort

Coronary Artery Disease
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
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July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

Cases:

  1. Previously enrolled in the CAD module of the Genebank at Scripps Clinic Registry
  2. Eligible to have their blood drawn
  3. Be reliable, cooperative and willing to comply with all protocol-specified procedures
  4. Able to understand and grant informed consent

Controls:

  1. Previously enrolled in the Healthy Elderly Active Longevity (HEAL) Cohort
  2. Eligible to have their blood drawn
  3. Be reliable, cooperative and willing to comply with all protocol-specified procedures
  4. Able to understand and grant informed consent

Exclusion Criteria:

  1. Unwilling or unable to grant informed consent.
  2. Have a significant medical condition that in the Investigator's opinion may interfere with subject's study participation.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01517425
11-5676
No
Eric Topol, MD, Scripps Translational Science Institute
Scripps Translational Science Institute
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Scripps Translational Science Institute
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP