Condition category
Circulatory System
Date applied
29/01/2007
Date assigned
26/03/2007
Last edited
05/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Reza Razavi

ORCID ID

Contact details

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

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

http://www.guysandstthomas.nhs.uk/home.aspx

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

  1. 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.

Additional files

Editorial Notes