- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00446160
Adult Congenital Heart Disease Surgery
Proposal for Retrospective Review of an Adult Congenital Heart Surgery Program
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.
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Retrospective chart review
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Subhadra E Shashidharan, MD, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00002790
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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