iPSC Repository of Pediatric Cardiovascular Disease

Sponsor
Mingtao Zhao (Other)
Overall Status
Recruiting
CT.gov ID
NCT05550324
Collaborator
(none)
300
1
54
5.6

Study Details

Study Description

Brief Summary

Obtain blood samples for generation and maintenance of induced pluripotent stem cells (iPSCs) and genomic/DNA sequencing for biomedical research that will improve the understanding and treatment of pediatric cardiovascular disease

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood draw

Detailed Description

Human induced pluripotent stem cells (iPSCs) are a type of pluripotent stem cell which can be generated from easily accessible patient cells, such as peripheral blood mononuclear cells and skin fibroblasts. As iPSCs are epigenetically reprogrammed from somatic cells, they retain all genetic information of the affected patients, thus providing an ideal model for studying the contribution of genetic variation to pediatric cardiovascular disease. In addition, human iPSCs can be differentiated into cardiomyocytes, endothelial cells, smooth muscle cells and cardiac fibroblasts, which are major affected cell types in the heart responsible for cardiovascular disease. Therefore, patient-specific iPSCs possess great promise in modeling pediatric cardiovascular disease, discovering novel drugs and prospective cell regeneration therapy.

The DNA from these patients will be analyzed for point mutations, rare sequence variations, single nucleotide polymorphisms in known cardiac development genes or for chromosomal copy number changes by using state of the art genetic approaches.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Family-Based
Time Perspective:
Prospective
Official Title:
iPSC Repository of Pediatric Cardiovascular Disease
Actual Study Start Date :
Jul 2, 2021
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Affected Subjects

The subjects must have the diagnosis of cardiovascular disease

Procedure: Blood draw
One time intravenous blood draw

Syndromes associated with Cardiovascular Disease

The subject must have a syndrome associated with cardiovascular disease

Procedure: Blood draw
One time intravenous blood draw

Family Members

The subject must be related to an individual in cohort 1 or 2

Procedure: Blood draw
One time intravenous blood draw

Controls

The subject is considered a control and does not fall into any of the other cohorts

Procedure: Blood draw
One time intravenous blood draw

Outcome Measures

Primary Outcome Measures

  1. improve the understanding and treatment of pediatric cardiovascular disease [up to 10 Years]

    This is a repository of blood samples that will be used into the future for medical research to improve the understanding and treatment of pediatric cardiovascular disease

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. The subjects must have the diagnosis of cardiovascular disease

  2. The subject must have a syndrome associated with cardiovascular disease

  3. The subject must be related to an individual in cohort 1 or 2

  4. The subject is considered a control and does not fall into any of the other cohorts

Exclusion Criteria:

N/A

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nationwide Children's Hospital Columbus Ohio United States 43205

Sponsors and Collaborators

  • Mingtao Zhao

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mingtao Zhao, Research Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT05550324
Other Study ID Numbers:
  • STUDY00001788
First Posted:
Sep 22, 2022
Last Update Posted:
Sep 22, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mingtao Zhao, Research Principal Investigator, Nationwide Children's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2022