Myocardial Contrast Echocardiography in Congenital Heart Disease

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00412685
First received: December 15, 2006
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

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.


Condition
D-Transposition of Great Arteries
Tetralogy of Fallot

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Quantification of the Myocardial Microcirculation by Contrast Echocardiography In Adult Patients With Congenital Heart Disease

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Further study details as provided by University Hospital Inselspital, Berne:

Enrollment: 45
Study Start Date: August 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412685

Locations
Switzerland
University Hospital Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Christian Seiler, Prof. University Hospital Berne, Switzerland
  More Information

No publications provided

Responsible Party: Christian Seiler, MD, Professor and Co-Chairman of Cardiology, Department of Cardiology, University Hospital, CH-3010 Bern, Switzerland
ClinicalTrials.gov Identifier: NCT00412685     History of Changes
Other Study ID Numbers: 70/06
Study First Received: December 15, 2006
Last Updated: October 25, 2010
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Tetralogy of Fallot
Transposition of Great Vessels
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 16, 2014