Myocardial Contrast Echocardiography in Congenital Heart Disease
Quantification of the Myocardial Microcirculation by Contrast Echocardiography In Adult Patients With Congenital Heart Disease
1 other identifier
observational
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2006
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 15, 2006
CompletedFirst Posted
Study publicly available on registry
December 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJune 16, 2015
June 1, 2015
2.3 years
December 15, 2006
June 15, 2015
Conditions
Study Arms (3)
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.
Eligibility Criteria
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.
You may qualify if:
- D-TGA or Fallot-Tetralogy or Healthy person
- written informed consent
- Age \>= 18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Inselspital
Bern, 3010, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Seiler, Prof.
University Hospital Berne, Switzerland
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 15, 2006
First Posted
December 18, 2006
Study Start
August 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
June 16, 2015
Record last verified: 2015-06