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Congenital Heart Disease Research Registry (CHDRR)

This study has been terminated.
(Insufficient funding)
Information provided by (Responsible Party):
William T. Mahle, MD, Emory University Identifier:
First received: September 22, 2008
Last updated: December 8, 2014
Last verified: December 2014
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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Congenital Heart Disease Research Registry

Resource links provided by NLM:

Further study details as provided by William T. Mahle, MD, Emory University:

Primary Outcome Measures:
  • 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
Blood and serum collected from Registry subjects will be cryopreserved for potential future genetic and/or protein-based studies.

Enrollment: 861
Study Start Date: January 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Congenital heart disease
All subjects will have known or suspected congenital heart disease

Detailed Description:

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with suspected or diagnosed with congenital heart disease receiving care at Children's Healthcare of Atlanta or Emory University Adult Congenital Heart Clinic

Inclusion Criteria:

  • All patients suspected or diagnosed with congenital heart disease receiving care at Children's Healthcare of Atlanta or Emory University Adult Congenital Heart Clinic and willing to sign informed consent.

Exclusion Criteria:

  • Not referred or diagnosed with CHD
  • No informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00757510

United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Principal Investigator: Paul M Kirshbom, MD Emory University
  More Information

Responsible Party: William T. Mahle, MD, Associate Professor, Emory University Identifier: NCT00757510     History of Changes
Other Study ID Numbers: IRB00006304
Study First Received: September 22, 2008
Last Updated: December 8, 2014

Keywords provided by William T. Mahle, MD, Emory University:
Congenital Heart Disease

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities processed this record on May 25, 2017