NCT01300221

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

Same day

First QC Date

February 17, 2011

Last Update Submit

September 4, 2013

Conditions

Congenital Heart Disease

Keywords

Three dimension echocardiographyCongenital heart diseaseZ-score

Study Arms (5)

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

Eligibility Criteria

Age1 Hour - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Subjects with diagnosis that fits into Group 1 to 5 and who are willing to participate (consent/assent obtained)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University College of Medicine/St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Shuping Ge, MD

    Drexel University College of Medicine/St. Christopher's Hospital for Children

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 21, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(1)