Adult Congenital Heart Disease Surgery

Sponsor
Emory University (Other)
Overall Status
Completed
CT.gov ID
NCT00446160
Collaborator
(none)
700
1
198
3.5

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    700 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Proposal for Retrospective Review of an Adult Congenital Heart Surgery Program
    Study Start Date :
    Jan 1, 2000
    Actual Primary Completion Date :
    Jul 1, 2016
    Actual Study Completion Date :
    Jul 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. 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. [Retrospective chart review]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Emory University Atlanta Georgia United States 30322

    Sponsors and Collaborators

    • Emory University

    Investigators

    • Principal Investigator: Subhadra E Shashidharan, MD, Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Subhadra Shashidharan, Assistant Professor, Emory University
    ClinicalTrials.gov Identifier:
    NCT00446160
    Other Study ID Numbers:
    • IRB00002790
    First Posted:
    Mar 12, 2007
    Last Update Posted:
    Feb 21, 2019
    Last Verified:
    Feb 1, 2019
    Keywords provided by Subhadra Shashidharan, Assistant Professor, Emory University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 21, 2019