Text Size

Hepatitis C in Adults Who Underwent Congenital Heart Surgery Before Screening

This study has been terminated.
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00359099
First received: July 31, 2006
Last updated: May 21, 2007
Last verified: May 2007
History of Changes
  Purpose

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
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Estimated Enrollment: 1000
Study Start Date: January 1980
Estimated Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359099

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: William T Mahle, MD Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00359099     History of Changes
Other Study ID Numbers: 762-2006
Study First Received: July 31, 2006
Last Updated: May 21, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Hepatic Medicine
Surgery

Additional relevant MeSH terms:
Heart Diseases
Hepatitis
Hepatitis A
Hepatitis C
Heart Defects, Congenital
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 19, 2013