Hepatitis C in Adults Who Underwent Congenital Heart Surgery Before Screening

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

Tracking Information

• First Submitted Date: July 31, 2006
• First Posted Date: August 1, 2006
• Last Update Posted Date: November 27, 2013
• Study Start Date: January 1980
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Hepatitis C in Adults Who Underwent Congenital Heart Surgery Before Screening
• Official Title: Proposal for Retrospective Review of the Prevalence of Hepatitis C Infection in Adult Patients Who Underwent Congenital Heart Surgery Before Screening
• 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.

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 Type: Observational
• Study Design: Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Not Provided
• Study Population: Not Provided
• Condition: Congenital Heart Disease
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Enrollment (submitted: July 31, 2006): 1000
• Original Enrollment: Same as current
• Study Completion Date: July 2006
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00359099
• Other Study ID Numbers: 0762-2006
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: William T. Mahle, MD, Emory University
• Study Sponsor: Emory University
• Collaborators: Not Provided

Investigators

• Principal Investigator: William T Mahle, MD; Emory University

• PRS Account: Emory University
• Verification Date: November 2013