- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00366847
Computer Modeling of Congenital Heart Disease
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Children's Healthcare of Atlanta
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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RV Function
Lasso di tempo: 1/1/1990- 3/14/2007
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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.
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1/1/1990- 3/14/2007
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Marijn E Brummer, PhD, Children's Healthcare of Atlanta
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Primo Inserito (Stima)
Aggiornamenti dei record di studio
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 06-149
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .