Improved Diagnosis of Congenital Heart Disease by MRI using Vasovist - CHD Vasovist - CHD Vasovist
Phase 1
- Conditions
- Congenital Heart DiseaseMedDRA version: 9.1 Level: LLT Classification code 10010495 Term: Congenital heart disease NOS
- Registration Number
- EUCTR2006-007042-18-GB
- Lead Sponsor
- Kings College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 27
Inclusion Criteria
Adult patients with congenital heart disease:
•Complex congenital defects
•Aortic abnormalities
•Pulmonary artery abnormalities
•Systemic or pulmonary venous abnormalities
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
•Any contra-indications to MR (e.g. pacemakers)
•Known allergy to MR contrast agents
•Patients not agreeing to take part in study
•Pregnant women and nursing mothers
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: The primary objective of this study is to quantify the benefits of using a blood pool agent, Vasovist, for diagnosis and follow-up of congenital heart disease.<br> The study will compare the findings obtained with Vasovist with respect to a standard MR contrast agent (Gd-DTPA).<br> Image quality, signal-to-noise ratio (SNR) and contrast-to-noise-ratio (CNR) will be assessed and compared between standard-Gd and Vasovist.<br> ;Secondary Objective: None;Primary end point(s): To determine the efficacy of the vasovist versus magnevist by comparing the image quality, signal-to-noise ratio (SNR) and contrast-to-noise-ratio (CNR) between standard-Gd and Vasovist.
- Secondary Outcome Measures
Name Time Method