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Hepatitis C in Adults Who Underwent Congenital Heart Surgery Before Screening

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ClinicalTrials.gov Identifier: NCT00359099
Recruitment Status : Terminated
First Posted : August 1, 2006
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
William T. Mahle, MD, Emory University

Study Description
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Brief 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.

Condition or disease
Congenital Heart Disease

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
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Study Type : Observational
Enrollment : 1000 participants
Time Perspective: Retrospective
Official Title: Proposal for Retrospective Review of the Prevalence of Hepatitis C Infection in Adult Patients Who Underwent Congenital Heart Surgery Before Screening
Study Start Date : January 1980
Study Completion Date : July 2006

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients seen at Emory Adult Congenital Clinic
  • patients > 18 years of age
  • underwent surgery for congenital heart disease prior to 1992

Exclusion Criteria:

  • history of known hepatitis prior to congenital heart surgery
  • history of intravenous drug abuse
Contacts and Locations
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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): NCT00359099


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: William T Mahle, MD Emory University
More Information
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Responsible Party: William T. Mahle, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00359099    
Other Study ID Numbers: 0762-2006
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013
Keywords provided by William T. Mahle, MD, Emory University:
Hepatic Medicine
Surgery
Additional relevant MeSH terms:
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Hepatitis C
Heart Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Cardiovascular Diseases