Improved Diagnosis of Congenital Heart Disease by MRI using Vasovist - CHD Vasovist - CHD Vasovist

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-007042-18-GB

Enrollment

Registered

2009-01-14

Start date

2007-03-08

Completion date

Unknown

Last updated

2019-04-30

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

Conditions

Congenital Heart Disease MedDRA version: 9.1 Level: LLT Classification code 10010495 Term: Congenital heart disease NOS

Interventions

Trade Name: VASOVIST 0.25 mmol/ml, solution for injection Pharmaceutical Form: Solution for injection INN or Proposed INN: gadofosveset trisodium Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. The study will compare the findings obtained with Vasovist with respect to a standard MR contrast agent (Gd-DTPA). Image quality, signal-to-noise ratio (SNR) and contrast-to-noise-ratio (CNR) will be assessed and compared between standard-Gd and Vasovist. ;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.	—

Measure

Time frame

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. The study will compare the findings obtained with Vasovist with respect to a standard MR contrast agent (Gd-DTPA). Image quality, signal-to-noise ratio (SNR) and contrast-to-noise-ratio (CNR) will be assessed and compared between standard-Gd and Vasovist. ;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.

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Countries

United Kingdom

Outcome results

None listed

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