Congenital DisordersNCT00446160
Adult Congenital Heart Disease Surgery
An observational study of Congenital Disorders, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Congenital Disorders
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to 1 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Those who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Congenital Disorders
- Keywords
- Congenital Heart Disease, Surgery, Adult
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospective chart review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2007 (estimated)
- Study startJan 2000
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhadra Shashidharan, Emory University
- Investigators
- Subhadra E Shashidharan, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446160
- Sponsor's protocol ID
- IRB00002790
- Status last verified
- Feb 2019
- First submitted
- 9 Mar 2007
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal for Retrospective Review of an Adult Congenital Heart Surgery Program
- ClinicalTrials.gov ID
- NCT00446160
- Acronym / sponsor ID
- IRB00002790
- Conditions
- Congenital Disorders
- Keywords
- Congenital Heart Disease, Surgery, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 12 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Those who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subhadra E Shashidharan, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.