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
  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 Scripps Translational Science Institute:

Primary Outcome Measures:
  • iPSC development [ Time Frame: five years ] [ Designated as safety issue: No ]
    Develop methods of iPSC generation from patients with genomic risk.


Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517425

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

No publications provided

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
Study First Received: January 20, 2012
Last Updated: April 4, 2014
Health Authority: United States: Scripps IRB

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

ClinicalTrials.gov processed this record on October 20, 2014