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Real-time 3-Dimensional Echocardiography for Assessment of Cardiac Function and Congenital Heart Disease (3DE-CHD)

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ClinicalTrials.gov Identifier: NCT01300221
Recruitment Status : Withdrawn (Study did not receive IRB approval.)
First Posted : February 21, 2011
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The propose of this study is to generate normative data of the tree-dimensional echocardiographic(3-DE) measurements for cardiac structure and function in a large cohort of normal infants, children,and adolescents. The investigators also sought to investigate the utility of 3-DE in evaluating infants, children and adolescents with congenital and acquired heart diseases.

Condition or disease
Congenital Heart Disease

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-time 3-Dimensional Echocardiography for Assessment of Cardiac Function and Congenital Heart Disease
Study Start Date : February 2011
Primary Completion Date : February 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Group 1
Subjects who are healthy normal children.
Group 2
Subjects who have congenital heart disease.
Group 3
Subjects who have sickle cell disease
Group 4
Subjects who have Duchenne muscular dystrophy
Group 5
Patients who have Marfan syndrome and other aortic disease


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Group 1. (n=300) Subjects who are healthy normal children. Group 2. (n=300) Subjects who have congenital heart disease. Group 3. (n=100) Subjects who have sickle cell disease. Group 4. (n=50) Subjects who have Duchenne muscular dystrophy. Group 5. (n=50) Subjects who have Marfan syndrome and aortic disease.
Criteria

Inclusion Criteria:

  • Subjects with diagnosis that fits into Group 1 to 5 and who are willing to participate (consent/assent obtained)
  • Do not meet the exclusion criteria (as follows).

Exclusion Criteria:

  • Unwilling to participate or give consent.
  • Clinically unstable.
  • Unable to co-operate.
  • Poor acoustic windows.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300221


Locations
United States, Pennsylvania
Drexel University College of Medicine/St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Drexel University
Investigators
Principal Investigator: Shuping Ge, MD Drexel University College of Medicine/St. Christopher's Hospital for Children
More Information

Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT01300221     History of Changes
Other Study ID Numbers: H-16888
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Keywords provided by Drexel University:
Three dimension echocardiography
Congenital heart disease
Z-score

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities