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Racial Distribution of Heterotaxy Syndrome

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ClinicalTrials.gov Identifier: NCT00485654
Recruitment Status : Terminated (study was terminated because study conclusions varied.)
First Posted : June 13, 2007
Last Update Posted : March 16, 2012
Sponsor:
Information provided by:

Study Description
Brief Summary:

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.


Condition or disease
Congenital Disorders

Detailed Description:

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.


Study Design

Study Type : Observational
Actual Enrollment : 65 participants
Time Perspective: Retrospective
Official Title: Racial Distribution of Heterotaxy Syndrome and Effects on Clinical Outcomes Protocol
Study Start Date : January 1990
Primary Completion Date : January 2005
Study Completion Date : February 2008

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U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT00485654


Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Rose M Cummings, DO Sibley Heart Center Cardiology at Children's Healthcare of Atlanta
More Information

Responsible Party: Director Research, Children's Healthcare of Atlanta Institutional Review Board
ClinicalTrials.gov Identifier: NCT00485654     History of Changes
Other Study ID Numbers: 06-198
First Posted: June 13, 2007    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: February 2008

Keywords provided by Children's Healthcare of Atlanta:
Heterotaxy Syndrome
Intestinal Malrotation
Functional Asplenia
Complex Cyanotic heart disease

Additional relevant MeSH terms:
Heterotaxy Syndrome
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Splenic Diseases
Lymphatic Diseases
Abnormalities, Multiple
Congenital Abnormalities