NCT00366847

Brief Summary

This proposal is aimed at developing a novel method for modeling and analyzing clinical factors impacting RV function, which can lead to a more reliable, consistent, and comprehensive pre-operative treatment planning. In particular, the proposed work centers on the creation of an accurate and clinically useful heart model with which to quantify, visualize, and interpret several clinical findings that are central to the medical decision-making process. The hypothesis is that by providing clinicians with 3D models that capture numerous relevant patient findings in an integrated, quantitative manner they can make more consistent, reliable, and accurate clinical assessments and may also be able to predict factors complicit in RV dysfunction and impending failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2001

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

10.8 years

First QC Date

August 17, 2006

Last Update Submit

May 7, 2014

Conditions

Congenital Disorders

Keywords

cardiacMRIpediatrics

Outcome Measures

Primary Outcomes (1)

  • RV Function

    This proposal is aimed at developing a novel method for modeling and analyzing clinical factors impacting RV function, which can lead to a more reliable, consistent, and comprehensive pre-operative treatment planning.

    1/1/1990- 3/14/2007

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This is a chart review of patients with heart defects associated with Right Ventricle dysfunction who have received a cardiac MRI at Children's Healthcare of Atlanta between January 1, 1990 and March 14, 2007.

You may qualify if:

  • Choa patients only. Data will be taken from the following patient groups:
  • Normal right ventricular (RV) EF with normal RV size and pulmonary insufficiency (PI)
  • Normal RV EF with dilated RV and PI
  • Reduced RV EF with dilated RV with PI
  • Normal RV EF (pre-operatively) dilated RV and pulmonary valve
  • replacement
  • Reduced RV EF (pre-op) dilated RV and pulmonary valve replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Marijn E Brummer, PhD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

June 1, 2001

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations

US(1)