NCT05550324

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress51%
Jul 2021Dec 2030

Study Start

First participant enrolled

July 2, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

February 25, 2025

Status Verified

February 1, 2024

Enrollment Period

9.5 years

First QC Date

August 8, 2022

Last Update Submit

February 22, 2025

Conditions

Keywords

iPSC

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 10 Years

Study Arms (4)

Affected Subjects

The subjects must have the diagnosis of cardiovascular disease

Procedure: Blood draw

Syndromes associated with Cardiovascular Disease

The subject must have a syndrome associated with cardiovascular disease

Procedure: Blood draw

Family Members

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

Procedure: Blood draw

Controls

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

Procedure: Blood draw

Interventions

Blood drawPROCEDURE

One time intravenous blood draw

Affected SubjectsControlsFamily MembersSyndromes associated with Cardiovascular Disease

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any individual with or without pediatric cardiovascular disease

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

6-12mL blood sample depending on age of patient

MeSH Terms

Conditions

Heart Defects, CongenitalHeart Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Principal Investigator

Study Record Dates

First Submitted

August 8, 2022

First Posted

September 22, 2022

Study Start

July 2, 2021

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

February 25, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Protected health information will only be shared if subjects consent to future research section of informed consent form

Locations