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Computer Modeling of Congenital Heart Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00366847
First received: August 17, 2006
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition
Congenital Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Computer Modeling of Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Primary Outcome Measures:
  • RV Function [ Time Frame: 1/1/1990- 3/14/2007 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: June 2001
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Detailed Description:

The research proposed here is motivated by the need to support pediatric cardiologists in making image-based decisions in the assessment and management of congenital heart disease (CHD). In marked contrast to adult cardiology, which deals almost exclusively with the left ventricle (LV), the function of the RV is associated with a number of life-threatening conditions in pediatrics. These defects include Hypoplastic Left Heart Syndrome (HLHS), Congenitally Corrected Transposition of Great Arteries, Post operative Tetralogy of Fallot, and Double Outlet Right Ventricle.

In particular, a computer model that simulates both the myocardium and blood pool of the right ventricle (RV) is being investigated that can be used to measure clinically useful but diverse parameters of RV blood flow and wall behaviors that previously would require multiple analysis tools to acquire. The model is based on data from MRI studies of patients. Alternate measurement techniques such as ultrasound and catheter pressure measurements are needed to verify the efficacy of the model.

Through a retrospective chart review of CHD patients with defects associated with RV dysfunction, data will be obtained from CHOA over a five year period, June 1, 2001 through May 31, 2006. It will be collected from 10 children aged 0-18 years. Magnetic Resonance images, Ultrasound and catheterization measurements will be collected and analyzed.

Data from MR will be used primarily to determine RV volumetric data. This information will be used to determine RV shape at the different stages of systole and through diastole. The RV shapes are the input to the computer model. The computer model will determine relevant clinical measures such as ejection fraction, pressure measurements, strain rate, and wall thickening based solely on the MR image data. The ultrasound and catheter data will be used as independent sources of verification against the data determined from the computer model. Ultrasound data will be used to compare ejection fraction and wall behavior to the predictive model and catheter data will be used to compare pressure measurements.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Those who do not conform with inclusion criteria
  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: NCT00366847

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Marijn E Brummer, PhD Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00366847     History of Changes
Other Study ID Numbers: 06-149
Study First Received: August 17, 2006
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:
cardiac
MRI
pediatrics

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 25, 2014