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Racial Distribution of Heterotaxy Syndrome

This study has been terminated.
(study was terminated because study conclusions varied.)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00485654
First received: June 12, 2007
Last updated: March 14, 2012
Last verified: February 2008

June 12, 2007
March 14, 2012
January 1990
January 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00485654 on ClinicalTrials.gov Archive Site
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Racial Distribution of Heterotaxy Syndrome
Racial Distribution of Heterotaxy Syndrome and Effects on Clinical Outcomes Protocol

Heterotaxy syndrome is a heterogeneous disease that is the result of a failure of normal right-left lateralization of the abdominal and thoracic organs during development. The major clinical manifestations include intestinal malrotation, functional asplenia and complex cyanotic heart disease.

Hypothesis: There exists a yet, un-recognized, racial distribution in heterotaxy syndrome.

The exact etiology of heterotaxy is unknown, but presumed to be multifactorial. While candidate genes have been suggested, no common gene has proven responsible for this constellation of lesions. Various modes of inheritance have been described. Though there are reports of familial occurrences, no reports of racial/ethnic predominance exist. We, therefore, propose to examine the racial/ethnic distribution of heterotaxy syndrome with congenital heart disease in patients treated at this institution. In addition, the investigators will determine if race/ethnicity is a factor in clinical outcomes.

Aim 1: To determine any pattern of racial/ethnic predominance within a cohort of patients with heterotaxy syndrome with congenital heart disease.

Aim 2: To correlate race/ethnicity with disparities in morbidity and mortality in patients with heterotaxy syndrome with congenital heart disease.

This study will be a retrospective, chart review of approximately 90 - 100 medical charts, conducted on the Egleston campus of Children's Healthcare of Atlanta. Charts reviewed will cover a period between January 1, 1990 and December 31, 2005.

Data to be collected includes: DOB, diagnosis, surgical procedure, surgical outcome, survival, length of hospitalization, repeat surgical intervention, incidence of hospitalization, length of inotropic support, ventilator time, infection rate, insurance provider, list of antibiotics and zip code of residence at initial admission. In addition to the above information, data to be extracted from the medical chart of a decedent will include age at death, cause of death, laboratory data at time of death and autopsy results.

Observational
Time Perspective: Retrospective
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Non-Probability Sample

This study will be a retrospective chart review of approximately 90 - 100 medical charts, conducted on the Egleston campus of Children's Healthcare of Atlanta. Charts reviewed will cover a period between January 1, 1990 and December 31, 2005. Data to be collected includes: DOB, diagnosis, surgical procedure, surgical outcome, survival, length of hospitalization, repeat surgical intervention, incidence of hospitalization, length of inotropic support, ventilator time, infection rate, insurance provider, list of antibiotics and zip code of residence at initial admission. In addition to the above information, data to be extracted from the medical chart of a decedent will include age at death, cause of death, laboratory data at time of death and autopsy results.

Congenital Disorders
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
65
February 2008
January 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All medical charts diagnosed clinically and at autopsy with heterotaxy syndrome, left atrial isomerism, right atrial isomerism or situs inversus totalis with congenital heart disease over a 16 consecutive year period at Children's Healthcare of Atlanta at Egleston.

Exclusion Criteria:

  • Those who do not meet Inclusion Criteria
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00485654
06-198
No
Director Research, Children's Healthcare of Atlanta Institutional Review Board
Children's Healthcare of Atlanta
Not Provided
Principal Investigator: Rose M Cummings, DO Sibley Heart Center Cardiology at Children's Healthcare of Atlanta
Children's Healthcare of Atlanta
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP