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ASSESSMENT OF GLOBAL AND REGIONAL LEFT VENTRICULAR FUNCTION AT REST AND DURING DOBUTAMINE STRESS WITH SONOVUE®-ENHANCED REALTIME 3D-ECHOCARDIOGRAPHY

ASSESSMENT OF GLOBAL AND REGIONAL LEFT VENTRICULAR FUNCTION AT REST AND DURING DOBUTAMINE STRESS WITH SONOVUE®-ENHANCED REALTIME 3D-ECHOCARDIOGRAPHY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-000357-22-DE
Enrollment
100
Registered
2006-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2013-02-25

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

Conditions

Echocardiography MedDRA version: 9.0 Level: LLT Classification code 10014116

Interventions

Product Name: SonoVue Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: sulfur hexafluoride CAS Number: 2551-62-4 Current Sponsor code: BR1 Concentration unit:

Sponsors

Bracco Imaging Deutschland GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Availability of results from a pre-study cath-lab examination (cine-ventriculography and coronary angiography) performed within 7 days before planned stress-echocardiography - Given indication for dobutamine stress-echocardiography - Given written Informed Consent to participate in the study. 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: - Age < 18 years - Pregnant or lactating woman - Known allergy against any of the ingredients of SonoVue® - Unstable cardiac condition according to the contraindications for SonoVue® (cf. SPC) - Any contraindication to dobutamine stress-echocardiography and/or cardiac MRI - Insufficient acoustic window for adequate echocardiographic examination - Participation in another clinical study with an investigational drug (up to 30 days before inclusion).

Design outcomes

Primary

MeasureTime frame
Main Objective: To prove the non-inferiority of SonoVue®-enhanced 3D (volume data) in comparison to SonoVue®-enhanced 2D echocardiogra-phy (apical 2CV+4CV) in determining the global ventricular function (ESV, EDV, EF) at rest. Basis of comparison will be the global ventricular function as determined by cardiac MRI.;Secondary Objective: To evaluate the accuracy and interobserver-variability for the assessment of cardiac volumes and cardiac wall motion in comparison to cardiac MRI.;Primary end point(s): Global ventricular function (ESV, EDV, EF)—

Countries

France, Germany

Outcome results

None listed

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