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

This study has been withdrawn prior to enrollment.
(Study did not receive IRB approval.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01300221
First Posted: February 21, 2011
Last Update Posted: September 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Drexel University
  Purpose
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
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-time 3-Dimensional Echocardiography for Assessment of Cardiac Function and Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Drexel University:

Enrollment: 0
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

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 Submitted: February 17, 2011
First Posted: February 21, 2011
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