A Phase 4 interventional study of Vasovist in Congenital Heart Disease, sponsored by Guy's Hospital. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-03.
Sponsored by Guy's Hospital · Phase 4, Interventional, and Diagnostic
Magnetic Resonance Imaging (MRI) is an effective and radiation free method of diagnosing Congenital Heart Disease (CHD). MRI works by taking images of the anatomy and physiology. These images also provide information on the hearts function and blood flow. The clarity of these images is enhanced by the use of contrast agents (dyes). However these agents only stay in the blood vessels for a short time and therefore limit the time in which the better quality images can be obtained. This study aims to determine whether MRI using Vasovist (a dye that stays in the vessels for a prolonged period of time) can improve the diagnosis of Congenital Heart Disease (CHD) by allowing more areas to be imaged and the improved assessment of various parameters (anatomy, volumes, flow) as well as vastly improving image quality.
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
Browse Heart Diseases studies →This is the only study on the registry with Guy's Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The main inclusion criteria will be patient with CHD, i.e. complex congenital defects such as:
Exclusion Criteria:
The study will involve MR contrast agents and and MRI scans, therefore the principle exclusion criteria are:
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
No secondary outcome measures.
This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.