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NCT00412685 Clinical Trial

Myocardial Contrast Echocardiography in Congenital Heart Disease

Tetralogy of Fallot Clinical Trial

Official title:
Quantification of the Myocardial Microcirculation by Contrast Echocardiography In Adult Patients With Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00412685
Other study ID # 70/06
Secondary ID
Status Completed
Phase N/A
First received December 15, 2006
Last updated June 15, 2015
Start date August 2006
Est. completion date December 2008

Study information
Verified date June 2015
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

Patients with congenital heart disease in whom the right ventricle is exposed to pressure or volume overload show progressive systolic dysfunction of the right ventricle, the fact of which conveys substantial morbidity and mortality. The aim of this study is to investigate the myocardial perfusion in these patients by myocardial contrast echocardiography (MCE) in order to determine whether disturbed blood flow plays a role in the development of right ventricular systolic dysfunction.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- D-TGA or Fallot-Tetralogy or Healthy person

- written informed consent

- Age >= 18 years

Exclusion Criteria:

- Anaemia

- Pregnancy and breast feeding

- Diabetes mellitus

- Contraindications to stress testing (ergometry or adenosine)

- Known adverse reaction or hypersensitivity against V08DA (SonoVue) or its components or against adenosine

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland University Hospital Inselspital Bern

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

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