NCT01517425

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
50mo left

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Nov 2012Jul 2030

First Submitted

Initial submission to the registry

January 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Expected
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

12.7 years

First QC Date

January 20, 2012

Last Update Submit

January 15, 2025

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • iPSC development

    Develop methods of iPSC generation from patients with genomic risk.

    five years

Study Arms (2)

Cases

Subjects previously enrolled in the Scripps Genebank Study

Controls

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Translational Science Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Scripps Translational Science Institute

Study Record Dates

First Submitted

January 20, 2012

First Posted

January 25, 2012

Study Start

November 1, 2012

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2030

Last Updated

January 16, 2025

Record last verified: 2025-01

Locations

US(1)