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

• Conditions: Echocardiography; MedDRA version: 8.1Level: LLTClassification code 10014116Term: Echocardiography

• Registration Number: EUCTR2006-000357-22-BE
• Lead Sponsor: Bracco ALTANA Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-04
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

- 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)