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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN23698917
Enrollment
20
Registered
2007-03-26
Start date
2007-03-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Sponsors

Guy's Hospital (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026