Evaluating Cardiovascular Phenotypes Using Induced Plurip... | NCT01517425

Studies
Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells

NCT01517425

Sponsor

Scripps Translational Science Institute

Status

Enrolling by invitation

Last Update Posted

Jan 16, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jul 2025Estimated

Completion Date

Jul 2030Estimated

First Submitted Date

Jan 20, 2012

First Submission Date that Met QC Criteria

Jan 20, 2012

First Posted Date

Jan 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2025

Last Update Posted Date

Jan 16, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eric Topol, MD, Director, Scripps Translational Science Institute, Scripps Translational Science InstitutePrincipal Investigator

Lead Sponsor

Scripps Translational Science InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cases		Subjects previously enrolled in the Scripps Genebank Study
Controls		Subjects previously enrolled in the Scripps Healthy Elderly Active Longevity (HEAL) Cohort

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
iPSC development	Develop methods of iPSC generation from patients with genomic risk.	five years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Translational Science Institute		La Jolla	California	92037	United States

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided