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iPSC Repository of Pediatric Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT05550324
Recruitment Status : Recruiting
First Posted : September 22, 2022
Last Update Posted : February 7, 2024
Sponsor:
Information provided by (Responsible Party):
Mingtao Zhao, Nationwide Children's Hospital

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Congenital Heart Disease Heart Diseases 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
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: iPSC Repository of Pediatric Cardiovascular Disease
Actual Study Start Date : July 2, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025
Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. improve the understanding and treatment of pediatric cardiovascular disease [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
6-12mL blood sample depending on age of patient

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any individual with or without pediatric cardiovascular disease
Criteria

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
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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): NCT05550324


Contacts
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Contact: Jade F Hayden, BSN 16143555648 jade.hayden@nationwidechildrens.org

Locations
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United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Jade Hayden    614-355-5648    jade.hayden@nationwidechildrens.org   
Sponsors and Collaborators
Mingtao Zhao
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Mingtao Zhao, Research Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT05550324    
Other Study ID Numbers: STUDY00001788
First Posted: September 22, 2022    Key Record Dates
Last Update Posted: February 7, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Protected health information will only be shared if subjects consent to future research section of informed consent form

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mingtao Zhao, Nationwide Children's Hospital:
iPSC
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities