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This study has been withdrawn prior to enrollment.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

History of Changes

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:

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

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 (Child, Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 September 23, 2016

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