- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00668824
Improved Diagnosis of Congenital Heart Disease by Magnetic Resonance Imaging Using Vasovist (CHD Vasovist)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
We planned an intra-individual study, where 20 adult patients with CHD (e.g. Fallot Tetralogy, s/p corrective surgery, single ventricle s/p Fontan operation, aortic and pulmonary artery stenosis) will undergo two examinations. Both scans are aimed to assess different diagnostic parameter like angiography, cardiac anatomy, ventricular volume and flow.
The first clinically indicated scan in our clinically established imaging protocol is performed using a standard contrast agent. The second scan is performed using a new protocol with Vasovist within the next seven days. Informed consent for the additional second scan will be obtained. In order to optimise the scan protocol for Vasovist we plan a pilot phase using three patients. Dosage of the two contrast agents will be within the approved dose. Any adverse events will be immediately reported. The following diagnostic parameters will be assessed and compared between standard Gadolinium (Gd) agent and Vasovist.
- MR-Angiography (MRA): assessment of the MRA quality of the large systemic and the pulmonary vessel (arterial and venous) by measuring the Contrast-to-Noise Ratio (CNR) and the vessel sharpness. In addition, the overall image-quality will be scored by three independent readers (scale: excellent, good, ok, bad).
- Cardiac Anatomy: assessment of image quality of the cardiac anatomy from 3D single/dual phase MRI by measuring Signal-to-Noise Ratio (SNR) and CNR as well as assessing the overall image quality by three independent readers (scale: excellent, good, ok, bad).
- Ventricular Volumes: comparison of systolic and diastolic volumes measured from multi-slice 2D short axis cine MRI, two single phases 3D whole heart MRI (diastole and systole).
- Flow: the different flow values will be measured in the large vessels using the Phase Contrast Angio (PCA) data. Furthermore, the flow reproducibility will be determined by using two scans. The overall scan-time to assess all these parameter will be approximately 40 minutes. The intra-individual study allows a direct comparison of the different parameters in a number of vascular territories.
Type d'étude
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
-
London, Royaume-Uni, SE1 7EH
- Recrutement
- Division of Imaging Sciences
-
Contact:
- Reza Razavi, MD
- Numéro de téléphone: 85440 020-7188-5440
- E-mail: reza.razavi@kcl.ac.uk
-
Chercheur principal:
- Reza Razavi, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
The main inclusion criteria will be patient with CHD, i.e. complex congenital defects such as:
- Aortic abnormalities
- Pulmonary artery abnormalities
- Systemic or pulmonary venous abnormalities
- The study will be limited to patients aged 18 and over
Exclusion Criteria:
The study will involve MR contrast agents and and MRI scans, therefore the principle exclusion criteria are:
- Any contra-indications to MR (e.g. pacemakers)
- Known allergy to MR contrast agents
- Patients not agreeing to take part in study
- Pregnancy and nursing mothers
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
---|
The improvement of diagnosis of CHD, due to larger coverage of vascular territories, higher spatial resolution, faster acquisition and higher quality of MR-flow measurements using Vasovist in comparison with standard Gd-agent
|
The improvement of image quality will be analysed by measuring the SNR, the CNR, the vessel sharpness. In addition, the overall image quality will be scored by three independent readers (scale: excellent, good, ok, bad)
|
Ventricular volumes measured from the acquired data will be compared with respect to a reference
|
The accuracy (standard deviation) and reproducibility of the flow measurements will be compared using the two different agents
|
Mesures de résultats secondaires
Mesure des résultats |
---|
No secondary outcome measures.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 07/Q0704/2
- ISRCTN23698917
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Maladie cardiaque congénitale
-
Region SkaneInscription sur invitationInsuffisance cardiaque New York Heart Association (NYHA) Classe II | Insuffisance cardiaque Classe III de la New York Heart Association (NYHA)Suède
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan... et autres collaborateursPas encore de recrutementInsuffisance cardiaque, systolique | Insuffisance cardiaque avec fraction d'éjection réduite | Insuffisance cardiaque New York Heart Association Classe IV | Insuffisance cardiaque Classe III de la New York Heart AssociationPologne
-
University of WashingtonAmerican Heart AssociationComplétéInsuffisance cardiaque, congestive | Altération mitochondriale | Insuffisance cardiaque New York Heart Association Classe IVÉtats-Unis
Essais cliniques sur Vasovist
-
Heidelberg UniversityRésiliéMaladie occlusive artérielle périphériqueAllemagne
-
Maastricht University Medical CenterComplétéTumeurs mammairesPays-Bas