Congenital DisordersNCT00268086
Constrictive Pericarditis in the Adult Congenital Cardiac Population
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
The primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis The secondary aim is to elucidate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Disorders
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients in the adult congenital heart disease clinic who have been diagnosed or operated on with constrictive pericarditis
Who cannot join
- those who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
The primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis
The secondary aim is to elucidate ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.
Read the detailed description
Constrictive pericarditis is a notoriously difficult diagnosis to reach. There are no signs, symptoms or pathognomonic diagnostic tests for pericardial constriction. In the adult congenital patients, it is also difficult. In addition, with pulmonary insufficiency, constrictive pericarditis may mask the findings of progressive right sided ventricular dilation and heart failure.
The primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis
The secondary aim is to elucidate ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.
Study Design and Methodology:
Retrospective chart review - approximately 15 patients
Preoperative data:
ECHO and cath findings
Operative data:
Operative findings
Postoperative data:
ECHO and cath findings
- Conditions
- Congenital Disorders
- Keywords
- constrictive pericarditis, adult congenital patients, pulmonary insufficiency
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Pericarditis, Constrictive, Respiratory Insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
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.
- 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
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Brian E Kogon, MD, Principal investigator, Emory Univ. SOM Cardiothoracic Surgery at Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268086
- Sponsor's protocol ID
- 05-123
- Status last verified
- Jun 2007
- First submitted
- 20 Dec 2005
- Last updated
- 13 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constrictive Pericarditis in the Adult Congenital Cardiac Population
- ClinicalTrials.gov ID
- NCT00268086
- Acronym / sponsor ID
- 05-123
- Conditions
- Congenital Disorders
- Keywords
- constrictive pericarditis, adult congenital patients, pulmonary insufficiency
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 15 participants
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- First posted
- 22 Dec 2005 (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.
The primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis
The secondary aim is to elucidate ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.
Detailed description
Constrictive pericarditis is a notoriously difficult diagnosis to reach. There are no signs, symptoms or pathognomonic diagnostic tests for pericardial constriction. In the adult congenital patients, it is also difficult. In addition, with pulmonary insufficiency, constrictive pericarditis may mask the findings of progressive right sided ventricular dilation and heart failure.
The primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis
The secondary aim is to elucidate ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.
Study Design and Methodology:
Retrospective chart review - approximately 15 patients
Preoperative data:
ECHO and cath findings
Operative data:
Operative findings
Postoperative data:
ECHO and cath findings
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients in the adult congenital heart disease clinic who have been diagnosed or operated on with constrictive pericarditis
Key exclusion criteria (1 listed)
- those who do not meet the 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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2007.
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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.
Brian E Kogon, MD principal investigator
Emory Univ. SOM Cardiothoracic Surgery at Children's Healthcare of Atlanta
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 Children's Healthcare of Atlanta 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 1 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: stopped early, as of the sponsor's last update on 13 Jun 2007. 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 was stopped early. Results are not available in the source record.
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.
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 13 Jun 2007.