Myocardial Contrast Echocardiography in Congenital Heart Disease

June 15, 2015 updated by: University Hospital Inselspital, Berne

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital Inselspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population is divided in three groups, which are all age- and gender-matched. The TGA group consists of 15 patients treated withMustard or Senning procedures for surgical repaired of D-TGA atrial switch operation. The TOF group consists of 15 patients with surgically corrected TOF. The control group C consists of 15 control subjects (AH) with normal Doppler Echocardiographic echocardiographic examinations.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
TGA group
The TGA group consists of 15 patients treated withMustard or Senning procedures for surgical repaired of D-TGA atrial switch operation.
TOF group
The TOF group consists of 15 patients with surgically corrected TOF.
Control group
The control group C consists of 15 control subjects (AH) with normal Doppler Echocardiographic echocardiographic examinations.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Christian Seiler, Prof., University Hospital Berne, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 15, 2006

First Submitted That Met QC Criteria

December 15, 2006

First Posted (Estimate)

December 18, 2006

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 15, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tetralogy of Fallot

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe