Myocardial Contrast Echocardiography in Congenital Heart Disease

NCT ID: NCT00412685

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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D-Transposition of Great Arteries Tetralogy of Fallot

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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TGA group

The TGA group consists of 15 patients treated withMustard or Senning procedures for surgical repaired of D-TGA atrial switch operation.

No interventions assigned to this group

TOF group

The TOF group consists of 15 patients with surgically corrected TOF.

No interventions assigned to this group

Control group

The control group C consists of 15 control subjects (AH) with normal Doppler Echocardiographic echocardiographic examinations.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Department of Cardiology, University Hospital, CH-3010 Bern, Switzerland

Principal Investigators

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Christian Seiler, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Berne, Switzerland

Locations

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University Hospital Inselspital

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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70/06

Identifier Type: -

Identifier Source: org_study_id

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