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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00268086
Other study ID # 05-123
Secondary ID
Status Terminated
Phase N/A
First received December 20, 2005
Last updated June 12, 2007

Study information

Verified date June 2007
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical 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 ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.


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


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients in the adult congenital heart disease clinic who have been diagnosed or operated on with constrictive pericarditis

Exclusion Criteria:

- those who do not meet the inclusion criteria

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Locations

Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

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