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Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells (iPSC)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01517425
First Posted: January 25, 2012
Last Update Posted: September 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
  Purpose
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.

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells

Further study details as provided by Eric Topol, MD, Scripps Translational Science Institute:

Primary Outcome Measures:
  • iPSC development [ Time Frame: five years ]
    Develop methods of iPSC generation from patients with genomic risk.


Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cases
Subjects previously enrolled in the Scripps Genebank Study
Controls
Subjects previously enrolled in the Scripps Healthy Elderly Active Longevity (HEAL) Cohort

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects previously enrolled in the Scripps Genebank or Healthy Elderly Active Longevity (HEAL) Cohort
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517425


Locations
United States, California
Scripps Translational Science Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
  More Information

Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT01517425     History of Changes
Other Study ID Numbers: 11-5676
First Submitted: January 20, 2012
First Posted: January 25, 2012
Last Update Posted: September 7, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases