Improved diagnosis of Congenital Heart Disease by magnetic resonance imaging using Vasovist

ISRCTN	ISRCTN23698917
DOI	https://doi.org/10.1186/ISRCTN23698917
ClinicalTrials.gov (NCT)	NCT00668824
Protocol serial number	1
Sponsor	Guy's Hospital (UK)
Funder	Schering (UK)

Submission date: 29/01/2007
Registration date: 26/03/2007
Last edited: 05/04/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Reza Razavi
Scientific

Imaging Sciences
5th Floor Thomas Guy House
Guy's Hospital
London
SE1 9RT
United Kingdom

Study information

Primary study design	Interventional
Study design	Non-randomised non-controlled clinical trial
Secondary study design	Single-centre
Study type	Participant information sheet
Scientific title
Study acronym	CHD Vasovist
Study objectives	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(s)	Approval received from the Guy's Research Ethics Committee on the 7th March 2007 (ref: 07/Q0704/2).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Vasovist
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Key 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
Key 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
Date of first enrolment	01/03/2007
Date of final enrolment	30/07/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Imaging Sciences

London
SE1 9RT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes