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Clinical Trials/EUCTR2006-000357-22-BE
EUCTR2006-000357-22-BE
Active, not recruiting
Not Applicable

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

Bracco ALTANA Pharma GmbH0 sites100 target enrollmentOctober 4, 2006
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ConditionsEchocardiographyMedDRA version: 8.1Level: LLTClassification code 10014116Term: Echocardiography
DrugsSonoVue

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Echocardiography
Sponsor
Bracco ALTANA Pharma GmbH
Enrollment
100
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 4, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Bracco ALTANA Pharma GmbH

Eligibility 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

  • •\- 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).

Outcomes

Primary Outcomes

Not specified

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