NCT00243776 Molecular and Cellular Characterization of Cardiac Tissue in Postnatal Development
| NCT ID | NCT00243776 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Congenital Heart Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2005-04 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2005-04 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study team will use small pieces of human hearts which are removed as part of a required surgical procedure to study different objectives. One of the objective is how calcium ions pass through the membrane of heart cells in order to tell the heart cell how much force to contract with when the heart beats. Investigators will also study the proteins and RNA of these pieces to determine how the newborn heart cells control their force of contraction differently from adult heart cells. Investigators hypothesize that infant hearts have different regulation of calcium entry than adult hearts. The study team also wants to study combinations of 3D cardiac spheres with multiple environmental cues that can improve functional and metabolic maturation of Human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) and generate a more clinically relevant cell model.
Eligibility Criteria
Inclusion Criteria: * Patients undergoing cardiopulmonary bypass surgery * Patients undergoing surgery for repair of congenital heart disease such as ventricular septal defect or defective mitral or aortic valves. Exclusion Criteria: * Prior cardiac surgery * History of atrial fibrillation or other atrial arrhythmias prior to operation * History of heart failure
Contact & Investigator
Michael E Davis, PhD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT00243776 clinical trial?
This trial is open to participants of all sexes, up to 20 Years, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00243776 currently recruiting?
Yes, NCT00243776 is actively recruiting participants. Contact the research team at medavis@emory.edu for enrollment information.
Where is the NCT00243776 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT00243776 clinical trial?
NCT00243776 is sponsored by Emory University. The principal investigator is Michael E Davis, PhD at Emory University. The trial plans to enroll 600 participants.