- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00668824
Improved Diagnosis of Congenital Heart Disease by Magnetic Resonance Imaging Using Vasovist (CHD Vasovist)
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Reza Razavi, MD
- Numero di telefono: 85440 020-7188-5440
- Email: reza.razavi@kcl.ac.uk
Luoghi di studio
-
-
-
London, Regno Unito, SE1 7EH
- Reclutamento
- Division of Imaging Sciences
-
Contatto:
- Reza Razavi, MD
- Numero di telefono: 85440 020-7188-5440
- Email: reza.razavi@kcl.ac.uk
-
Investigatore principale:
- Reza Razavi, MD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
---|
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
|
Misure di risultato secondarie
Misura del risultato |
---|
No secondary outcome measures.
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 07/Q0704/2
- ISRCTN23698917
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 .
Prove cliniche su Cardiopatia congenita
-
Region SkaneIscrizione su invitoInsufficienza cardiaca Classe II della New York Heart Association (NYHA). | Insufficienza cardiaca Classe III della New York Heart Association (NYHA).Svezia
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... e altri collaboratoriNon ancora reclutamentoInsufficienza cardiaca, sistolica | Insufficienza cardiaca con frazione di eiezione ridotta | Scompenso cardiaco Classe IV della New York Heart Association | Scompenso cardiaco Classe III della New York Heart AssociationPolonia
-
University of WashingtonAmerican Heart AssociationCompletatoInsufficienza cardiaca, congestizia | Alterazione mitocondriale | Scompenso cardiaco Classe IV della New York Heart AssociationStati Uniti
Prove cliniche su Vasovist
-
Heidelberg UniversityTerminatoMalattia occlusiva arteriosa perifericaGermania
-
Maastricht University Medical CenterCompletatoNeoplasie mammarieOlanda
-
Copenhagen University Hospital at HerlevRigshospitalet, DenmarkSconosciutoAterosclerosi | Claudicazione intermittenteDanimarca