Adult Congenital Heart Disease Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Brian Kogon, Emory University
ClinicalTrials.gov Identifier:
NCT00446160
First received: March 9, 2007
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

It is now estimated that the number of adults with congenital heart disease in the U.S is over 800,000. Unfortunately, these patients, in some way, have become a lost population. They have congenital abnormalities familiar to a children's hospital, yet have surpassed the age cutoff for admission.

Recently, we have developed a specialized program to care for this unique patient population. Dedicated programs such as ours hope to optimize patient care, consolidate specialized resources, provide sufficient patient numbers for training and maintain expertise and facilitate research in this unique population.


Condition
Congenital Disorders

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Proposal for Retrospective Review of an Adult Congenital Heart Surgery Program

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • The primary interest of the study is to look at the breakdown of our adult congenital program in regards to location, personnel, and case type. [ Time Frame: Retrospective chart review ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: January 2000
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Detailed Description:

In the United States, approximately 30,000 children are born with congenital heart disease every year. As technology, operative technique, and critical care medicine have improved significantly over the years, more of these children are surviving into adulthood.

Care of the congenital cardiac surgical patient requires a concerted effort on the part of the surgeons, perfusionists, anesthesiologists, intensivists, nurses, respiratory therapists, rehabilitation services and social workers. It is hoped that the same excellent care received in a children's congenital heart surgery program can be continued as these patients graduate into an adult program.

This is a retrospective chart review examining patients over the age of 18 years who have undergone operations for congenital heart disease. The primary interest of the study is to look at the breakdown of our adult congenital program in regards to location, personnel, and case type. All charts reviewed will be of patients who had their surgery at Children's Healthcare of Atlanta or Emory University between January 1, 2000 and December 31, 2006. We will review approximately 225 charts for this study.

The first aim of the study would be to examine the demographics of the adult congenital heart surgery program itself. The following information will be collected:

  • Location of the surgery - children's hospital vs adult hospital
  • Surgeon - adult cardiac surgeon vs congenital cardiac surgeon

The second aim of the study would be to analyze the types of surgeries being performed. The following information will be collected:

  • Pathologic diagnosis
  • Number of re-operative sternotomies
  • Number of open-heart surgeries

The third aim of the study would be to analyze our outcomes. The following information will be collected:

- Number of surgical mortalities

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This is a retrospective chart review examining patients over the age of 18 years who have undergone operations for congenital heart disease. The primary interest of the study is to look at the breakdown of our adult congenital program in regards to location, personnel, and case type. All charts reviewed will be of patients who had their surgery at Children's Healthcare of Atlanta or Emory University between January 1, 2000 and December 31, 2007. We will review approximately 350 charts for this study.

Some of the patients have been cared for in the system for many years, first at Egleston and then at Emory. We are only interested in the congenital operations performed on patients after the age of 18 years old up until approximately 65 years of age. Initially these were done at Egleston, although more recently they are being done at Emory.

Criteria

Inclusion Criteria:

  • surgery at Children's Healthcare of Atlanta or Emory University between 1.1.2000 and 12.31.2007
  • surgery on patients after 18 years to approximately 65 years of age

Exclusion Criteria:

  • Those who do not meet inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446160

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Brian E Kogon, MD Emory University
  More Information

No publications provided

Responsible Party: Brian Kogon, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00446160     History of Changes
Other Study ID Numbers: IRB00002790
Study First Received: March 9, 2007
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Congenital Heart Disease
Surgery
Adult

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 26, 2014