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

Completed

Conditions: Circulatory System
Other congenital malformations of heart
Congenital Heart Disease (CHD)

Registration Number: ISRCTN23698917

Lead Sponsor: Guy's Hospital (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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)<br>3. Ventricular volumes measured from the acquired data will be compared with respect to a reference<br>4. The accuracy (standard deviation) and reproducibility of the flow measurements will be compared using the two different agents

Secondary Outcome Measures