NCT00277901

Brief Summary

At Children's Healthcare of Atlanta at Egleston, it is standard of care to do a cardiac MRI on patients with the diagnosis of Tetralogy of Fallot and Aortic Coarctation to evaluate heart function. We propose to do a retrospective chart review of patient data along with their MRI data to analyze ventricular function and cavity volumes pre-Tetralogy of Fallot repair, post-Tetralogy of Fallot repair (pre-valve repair/replacement) and post-valve repair/replacement in order to assess the efficacy and optimal timing of valve replacement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2002

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

7.3 years

First QC Date

January 13, 2006

Last Update Submit

November 26, 2014

Conditions

Congenital Disorders

Keywords

cardiacpediatricMRITetralogy of Fallot TOFAortic Coarctation

Outcome Measures

Primary Outcomes (1)

  • (1) Determine Right and left ventricular volumes during all phases of the cardiac cycle.

    (1) Determine Right and left ventricular volumes during all phases of the cardiac cycle.

    7 years

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population is Patients with the diagnosis of Tetralogy of Fallot or Aortic Coarctation being Treated at Children's Healthcare of Atlanta at Egleston

You may qualify if:

  • Patients with the diagnosis of Tetralogy of Fallot or Aortic Coarctation being Treated at Children's Healthcare of Atlanta at Egleston.

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 AbnormalitiesAortic Coarctation

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital Abnormalities

Study Officials

  • James Parks, MD

    Children's Healthcare of Atlanta, Sibley Heart Center Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 18, 2006

Study Start

March 1, 2002

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

US(1)