Congenital Heart DiseaseNCT00359099
Hepatitis C in Adults Who Underwent Congenital Heart Surgery Before Screening
An observational study of Congenital Heart Disease, run by Emory University at 1 site in United States.
Trial summary
This is a retrospective chart review. We hypothesize that patients who have undergone congenital heart surgery, prior to screening of blood products have a significant risk of hepatitis C infection and all such patients would benefit from screening for hepatitis C. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1980to Jul 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients seen at Emory Adult Congenital Clinic
- patients > 18 years of age
- underwent surgery for congenital heart disease prior to 1992
Who cannot join
- history of known hepatitis prior to congenital heart surgery
- history of intravenous drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proposal for Retrospective Review of the Prevalence of Hepatitis C Infection in Adult Patients Who Underwent Congenital Heart Surgery Before Screening
This is a retrospective chart review. We hypothesize that patients who have undergone congenital heart surgery, prior to screening of blood products have a significant risk of hepatitis C infection and all such patients would benefit from screening for hepatitis C.
Read the detailed description
The Adult Congenital Clinic at Emory Hospital routinely screens all patients who have had congenital heart surgery prior to 1992 for hepatitis C antibodies. It is currently not the practice norm for all congenital heart patients to receive hepatitis screening unless they are at a specialized clinic that has implemented a system. The question of hepatitis C serology is particularly important for this population as many of these patients develop heart failure and may require heart transplantation and immunosuppression.
This is a retrospective analysis examining the prevalence of hepatitis C in the Adult Congenital Clinic at The Emory Clinic. The current practice is to screen all adult congenital heart disease patients for hepatitis C. All Emory clinic charts reviewed will be of patients who had congenital heart surgery. Only information on patients who had surgery prior to 1992 will be used for this study. We will review approximately 1000 charts for this study.
- Conditions
- Congenital Heart Disease
- Keywords
- Hepatic Medicine, Surgery
- Medical subject headings
- Heart Defects, Congenital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJan 1980
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William T. Mahle, MD, Emory University
- Investigators
- William T Mahle, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359099
- Sponsor's protocol ID
- 0762-2006
- Status last verified
- Nov 2013
- First submitted
- 31 Jul 2006
- Last updated
- 27 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal for Retrospective Review of the Prevalence of Hepatitis C Infection in Adult Patients Who Underwent Congenital Heart Surgery Before Screening
- ClinicalTrials.gov ID
- NCT00359099
- Acronym / sponsor ID
- 0762-2006
- Conditions
- Congenital Heart Disease
- Keywords
- Hepatic Medicine, Surgery
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1,000 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 1980
- Study completion
- Jul 2006
- First posted
- 1 Aug 2006 (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.
This is a retrospective chart review. We hypothesize that patients who have undergone congenital heart surgery, prior to screening of blood products have a significant risk of hepatitis C infection and all such patients would benefit from screening for hepatitis C.
Detailed description
The Adult Congenital Clinic at Emory Hospital routinely screens all patients who have had congenital heart surgery prior to 1992 for hepatitis C antibodies. It is currently not the practice norm for all congenital heart patients to receive hepatitis screening unless they are at a specialized clinic that has implemented a system. The question of hepatitis C serology is particularly important for this population as many of these patients develop heart failure and may require heart transplantation and immunosuppression.
This is a retrospective analysis examining the prevalence of hepatitis C in the Adult Congenital Clinic at The Emory Clinic. The current practice is to screen all adult congenital heart disease patients for hepatitis C. All Emory clinic charts reviewed will be of patients who had congenital heart surgery. Only information on patients who had surgery prior to 1992 will be used for this study. We will review approximately 1000 charts for this study.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients seen at Emory Adult Congenital Clinic
- patients > 18 years of age
- underwent surgery for congenital heart disease prior to 1992
Key exclusion criteria (2 listed)
- history of known hepatitis prior to congenital heart surgery
- history of intravenous drug abuse
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. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
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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.
William T Mahle, MD principal investigator
Emory University
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 Heart Disease, run by Emory University 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 3 inclusion and 2 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 27 Nov 2013. 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. 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 27 Nov 2013.