Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00668824
Protocol/serial number
1
Study information
Scientific title
Acronym
CHD Vasovist
Study hypothesis
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.
Ethics approval
Approval received from the Guy's Research Ethics Committee on the 7th March 2007 (ref: 07/Q0704/2).
Study design
Non-randomised non-controlled clinical trial
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Congenital Heart Disease (CHD)
Intervention
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.
1. 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).
2. 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).
3. 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).
4. 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.
Intervention type
Drug
Phase
Not Specified
Drug names
Vasovist
Primary outcome measures
1. 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
2. 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)
3. Ventricular volumes measured from the acquired data will be compared with respect to a reference
4. The accuracy (standard deviation) and reproducibility of the flow measurements will be compared using the two different agents
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/03/2007
Overall trial end date
30/07/2008
Reason abandoned
Eligibility
Participant inclusion criteria
The main inclusion criteria will be patient with CHD, i.e. complex congenital defects such as:
1. Aortic abnormalities
2. Pulmonary artery abnormalities
3. Systemic or pulmonary venous abnormalities
4. The study will be limited to patients aged 18 and over
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
The study will involve MR contrast agents and and MRI scans, therefore the principle exclusion criteria are:
1. Any contra-indications to MR (e.g. pacemakers)
2. Known allergy to MR contrast agents
3. Patients not agreeing to take part in study
4. Pregnancy and nursing mothers
Recruitment start date
01/03/2007
Recruitment end date
30/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Imaging Sciences
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Guy's Hospital (UK)
Sponsor details
c/o Jackie Pullen
R&D Dept
3rd Floor Conybeare House
St Thomas' Street
London
SE1 9RT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Schering (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21613441
Publication citations
-
Results
Makowski MR, Wiethoff AJ, Uribe S, Parish V, Botnar RM, Bell A, Kiesewetter C, Beerbaum P, Jansen CH, Razavi R, Schaeffter T, Greil GF, Congenital heart disease: cardiovascular MR imaging by using an intravascular blood pool contrast agent., Radiology, 2011, 260, 3, 680-688, doi: 10.1148/radiol.11102327.