Congenital Heart Disease Research Registry (CHDRR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00757510|
Recruitment Status : Terminated (Insufficient funding)
First Posted : September 23, 2008
Last Update Posted : December 9, 2014
|Condition or disease|
|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.
|Study Type :||Observational|
|Actual Enrollment :||861 participants|
|Official Title:||Congenital Heart Disease Research Registry|
|Study Start Date :||January 2008|
|Primary Completion Date :||February 2010|
|Study Completion Date :||February 2010|
Congenital heart disease
All subjects will have known or suspected congenital heart disease
- 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. ]
Biospecimen Retention: Samples With DNA
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): NCT00757510
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Paul M Kirshbom, MD||Emory University|