Congenital Heart Disease Research Registry (CHDRR)
The Congenital Heart Disease Research Registry (CHDRR) is a program dedicated to understanding the etiology and improving the treatment of Congenital Heart Disease (CHD). This Registry will act as a central coordinating center for recruiting subjects with CHD and will provide infrastructure and guidelines for researchers studying the causes and treatment of CHD. Investigators working directly with the Registry will have access to biological, demographic and phenotype data from a significant pool of participants with CHD.
Congenital Heart Disease
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Congenital Heart Disease Research Registry|
- There is no outcome measure. This is a data, blood and serum collection only to provide a base for future studies [ Time Frame: We will be collecting samples for a minimum of 40 years. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood and serum collected from Registry subjects will be cryopreserved for potential future genetic and/or protein-based studies.
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||January 2048|
|Estimated Primary Completion Date:||January 2048 (Final data collection date for primary outcome measure)|
Congenital heart disease
All subjects will have known or suspected congenital heart disease
The Registry will recruit participants from either new referrals for evaluation of potential CHD or from patients who are being followed within the Children's Healthcare of Atlanta Sibley Heart Center or Emory University Adult Congenital Heart Clinic with specific diagnoses and therapy. Participants will provide a biological sample (blood), demographic data, medical records and phenotypic data, and assessment data. These data will be stored in a secure database accessible only to investigators with research projects that have been approved by the IRB and by the executive committee of the CHDRR. The executive committee of the CHDRR will contain at least one member from each of the following: Sibley Heart Center, Emory Pediatric Cardiac Surgery Division, and Emory-Egleston Children's Research Center. This committee will meet quarterly to discuss patient enrollment, patient safety issues, and data integrity. They will also meet as needed to discuss any applications for sample utilization and study publications.
Blood and serum collected from Registry members will be cryopreserved for potential future genetic and/or protein-based studies. Note that no genotyping or analysis will be done by the Registry. The data collected is meant to give future researchers a base of information to establish eligibility for their specific studies. It is the goal of the Registry to work with researchers to gain IRB approval either to access scrubbed data or to contact Registry members for potential enrollment in any IRB-approved studies that would require access to private healthcare information (PHI).
Approved investigators can use the Registry database in two ways: 1) to query and extract data that have been scrubbed of identifiers, utilizing bar-code linked, de-identified blood or serum; and 2) to identify Registry members who are eligible for specific research projects requiring further patient contact. In the latter application, the investigators will identify potential participants via the scrubbed data, but will not have access to personal information during the initial identification process. The Registry research coordinator will then contact the identified Registry members, explain the study, and request consent to give their contact information to the investigator. The investigator will then contact consenting, eligible members using their IRB approved, project-specific protocol. In both applications, IRB approval will be required before the Registry database will be accessed or samples released for study. Further, investigators will be required to report participation outcomes of eligible Registry members to the Registry research coordinator. The Registry research coordinator will track participation/refusal/non-participation of each Registry member who is identified and contacted for additional research projects.
|Contact: Paul M Kirshbom, MDfirstname.lastname@example.org|
|Contact: Jeryl L Huckaby, AS, BSemail@example.com|
|United States, Georgia|
|Children's Healthcare of Atlanta||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Paul M Kirshbom, MD 404-785-6330 firstname.lastname@example.org|
|Contact: Jeryl L Huckaby, AS, BS 404-785-0040 email@example.com|
|Principal Investigator: Paul M Kirshbom, MD|
|Principal Investigator:||Paul M Kirshbom, MD||Emory University|