Congenital Heart DiseaseNCT05550324
IPSC Repository of Pediatric Cardiovascular Disease
An observational study of Congenital Heart Disease and Heart Diseases, run by Mingtao Zhao at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease, Heart Diseases
- What is being tested?
- Blood draw
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2021to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Any individual with or without pediatric cardiovascular disease
Who may be able to join
- The subjects must have the diagnosis of cardiovascular disease
- The subject must have a syndrome associated with cardiovascular disease
- The subject must be related to an individual in cohort 1 or 2
- The subject is considered a control and does not fall into any of the other cohorts
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Jade Hayden, 16143555648, jade.hayden@nationwidechildrens.org
About this study
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
Read the 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.
- Conditions
- Congenital Heart Disease, Heart Diseases
- Being tested
- Blood draw
- Keywords
- iPSC
- Medical subject headings
- Heart Defects, Congenital, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
One time intravenous blood draw
| Study group | Role | What they receive |
|---|---|---|
| Affected Subjects | The subjects must have the diagnosis of cardiovascular disease Receives: Procedure: Blood draw | |
| Syndromes associated with Cardiovascular Disease | The subject must have a syndrome associated with cardiovascular disease Receives: Procedure: Blood draw | |
| Family Members | The subject must be related to an individual in cohort 1 or 2 Receives: Procedure: Blood draw | |
| Controls | The subject is considered a control and does not fall into any of the other cohorts Receives: Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
improve the understanding and treatment of pediatric cardiovascular disease
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
Measured: up to 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start2 Jul 2021
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingtao Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mingtao Zhao, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550324
- Sponsor's protocol ID
- STUDY00001788
- Status last verified
- Feb 2024
- First submitted
- 8 Aug 2022
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protected health information will only be shared if subjects consent to future research section of informed consent form
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IPSC Repository of Pediatric Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05550324
- Acronym / sponsor ID
- STUDY00001788
- Conditions
- Congenital Heart Disease, Heart Diseases
- Keywords
- iPSC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mingtao ZhaoUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Affected Subjects | – | Procedure: Blood drawThe subjects must have the diagnosis of cardiovascular disease |
| Syndromes associated with Cardiovascular Disease | – | Procedure: Blood drawThe subject must have a syndrome associated with cardiovascular disease |
| Family Members | – | Procedure: Blood drawThe subject must be related to an individual in cohort 1 or 2 |
| Controls | – | Procedure: Blood drawThe subject is considered a control and does not fall into any of the other cohorts |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any individual with or without pediatric cardiovascular disease
Key inclusion criteria (4 listed)
- The subjects must have the diagnosis of cardiovascular disease
- The subject must have a syndrome associated with cardiovascular disease
- The subject must be related to an individual in cohort 1 or 2
- The subject is considered a control and does not fall into any of the other cohorts
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawOne time intravenous blood draw | Procedure or surgery | Affected Subjects, Controls, Family Members, Syndromes associated with Cardiovascular Disease |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No. Protected health information will only be shared if subjects consent to future research section of informed consent form
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Heart Diseases, run by Mingtao Zhao at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jade F Hayden, BSN (16143555648, jade.hayden@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improve the understanding and treatment of pediatric cardiovascular disease (time frame: up to 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.