Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
861 participants
OBSERVATIONAL
2008-01-31
2010-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Congenital heart disease
All subjects will have known or suspected congenital heart disease
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* No informed consent
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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William T. Mahle, MD
Associate Professor
Principal Investigators
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Paul M Kirshbom, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Countries
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References
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McElhinney DB, Geiger E, Blinder J, Benson DW, Goldmuntz E. NKX2.5 mutations in patients with congenital heart disease. J Am Coll Cardiol. 2003 Nov 5;42(9):1650-5. doi: 10.1016/j.jacc.2003.05.004.
Lambrechts D, Devriendt K, Driscoll DA, Goldmuntz E, Gewillig M, Vlietinck R, Collen D, Carmeliet P. Low expression VEGF haplotype increases the risk for tetralogy of Fallot: a family based association study. J Med Genet. 2005 Jun;42(6):519-22. doi: 10.1136/jmg.2004.026443. No abstract available.
Goldmuntz E. The genetic contribution to congenital heart disease. Pediatr Clin North Am. 2004 Dec;51(6):1721-37, x. doi: 10.1016/j.pcl.2004.08.006.
Walther T, Schubert A, Falk V, Binner C, Walther C, Doll N, Fabricius A, Dhein S, Gummert J, Mohr FW. Left ventricular reverse remodeling after surgical therapy for aortic stenosis: correlation to Renin-Angiotensin system gene expression. Circulation. 2002 Sep 24;106(12 Suppl 1):I23-6.
Kerstann KF, Feingold E, Freeman SB, Bean LJ, Pyatt R, Tinker S, Jewel AH, Capone G, Sherman SL. Linkage disequilibrium mapping in trisomic populations: analytical approaches and an application to congenital heart defects in Down syndrome. Genet Epidemiol. 2004 Nov;27(3):240-51. doi: 10.1002/gepi.20019.
Other Identifiers
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IRB00006304
Identifier Type: -
Identifier Source: org_study_id