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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Drexel University
ClinicalTrials.gov Identifier:
NCT01300221
First received: February 17, 2011
Last updated: September 4, 2013
Last verified: September 2013
  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

Ages Eligible for Study:   up to 19 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT01300221     History of Changes
Other Study ID Numbers: H-16888
Study First Received: February 17, 2011
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014