Congenital DisordersNCT00485654
Racial Distribution of Heterotaxy Syndrome
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Congenital Disorders
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1990to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Those who do not meet Inclusion Criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Disorders
- Keywords
- Heterotaxy Syndrome, Intestinal Malrotation, Functional Asplenia, Complex Cyanotic heart disease
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Heterotaxy Syndrome, Volvulus Of Midgut
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startJan 1990
- Primary completionJan 2005
- Study completionFeb 2008
Why it stopped: study was terminated because study conclusions varied.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Rose M Cummings, DO, Principal investigator, Sibley Heart Center Cardiology at Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485654
- Sponsor's protocol ID
- 06-198
- Status last verified
- Feb 2008
- First submitted
- 12 Jun 2007
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial Distribution of Heterotaxy Syndrome and Effects on Clinical Outcomes Protocol
- ClinicalTrials.gov ID
- NCT00485654
- Acronym / sponsor ID
- 06-198
- Conditions
- Congenital Disorders
- Keywords
- Heterotaxy Syndrome, Intestinal Malrotation, Functional Asplenia, Complex Cyanotic heart disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: study was terminated because study conclusions varied.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jan 1990
- Primary completion
- Jan 2005 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 13 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Those who do not meet Inclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: study was terminated because study conclusions varied.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rose M Cummings, DO principal investigator
Sibley Heart Center Cardiology at Children's Healthcare of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: study was terminated because study conclusions varied.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2012.