Congenital Heart Disease Research Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/7/2015 |
| Start Date: | January 2008 |
| End Date: | January 2048 |
| Contact: | Paul M Kirshbom, MD |
| Email: | pkirshb@emory.edu |
| Phone: | 404-785-6330 |
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.
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.
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.
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.
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
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