- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01668264
Imaging Assessment of Diastolic Function
Combined Echocardiographic and MRI Assessment of Diastolic Function in Patients With Congenital Heart Disease
Diastolic function is poorly studied in children with congenital heart disease. This is mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared to echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue characterization. The main advantage of echocardiography is a better temporal resolution which allows the study of short events like early relaxation. Overall there is a lack of studies correlating different echocardiographic and MRI parameters of heart function in pediatric populations with congenital or acquired heart diseases. This study will address specific questions on specific groups of patients that might bring more insight into chamber interaction and cardiac function. This study hypothesizes the following:
- Atrial enlargement is a marker of chronic increase in filling pressures and 3D echo might be the best method for follow-up.
- Cardiac remodeling associated with chronic loading results in changes in diastolic properties related to changes in cardiac mass and volume. This is related to changes in cardiac mechanics influencing diastolic parameters. Especially the influence on twisting and untwisting will be studied.
- Regional myocardial fibrosis and scarring may account for regional systolic and diastolic dysfunction with possible prognostic impact
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- All patients with tetralogy of Fallot post repair, transposition of great arteries after arterial switch operation, aortic valvulopathy (aortic stenosis and aortic regurgitation), coarctation of the aorta and cardiomyopathy, who are planned to undergo a cardiac MRI will be eligible.
- Informed consent
Exclusion Criteria:
- Lack of informed consent
- Need for general anesthesia
- Similar contraindications as for a clinical MRI study apply.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Magnetic Resonance Imaging (MRI)
Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
|
|
|
Expérimental: Echocardiograph
Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Atrial Volumes
Délai: Day 1
|
Measure right and left atrial volumes by 2D and 3D echo and correlate the different echocardiographic measurements with MRI.
This will allow identifying the most accurate measurement which can be used in clinical practice.
|
Day 1
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Assess Ventricular Volumes
Délai: Day 1
|
Assess ventricular volumes and mass and calculate mass/volume ratio.
Study the effect of ventricular remodeling on myocardial mechanics especially twisting and untwisting.
Relate these changes to evaluation of diastolic function.
|
Day 1
|
|
Myocardial Scarring
Délai: Day 1
|
Assess the presence of myocardial scarring in specific populations with congenital heart disease and correlate the findings with regional and global systolic and diastolic dysfunction.
|
Day 1
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Luc Mertens, MD, The Hospital for Sick Children
Dates d'enregistrement des études
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1000017963
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