New Three-dimensional Methods of Analysis for the Detection of Coronary Artery Disease by Dobutamine Stress Echocardiography
- Conditions
- Coronary Artery DiseaseEchocardiography, Stress
- Interventions
- Other: Stress-echocardiography
- Registration Number
- NCT02240745
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief Summary
The investigators are going to recruit patients who have a scheduled elective coronary angiography and going to do a dobutamin stress echography (DSE) before the coronary examination. Next to a regular 2D-DSE, the investigators will perform an 3-dimensional DSE, incl ventriculography. In the interventional part (coronary angiography), they will measure each stenosis with fractional flow-reserve (FFR)and herewith graduate its stenosis severity.
- Detailed Description
Background
Coronary heart disease is the leading cause of death worldwide. Non-invasive, radiation-free diagnostic needs further improvement. In this study, the investigators test the hypothesis that their method, which measures the myocardial deformation using 3D echocardiography is superior to previous ultrasound technologies with regard to diagnosis of stable coronary artery disease. The aim is establish an improved, non-invasive method to diagnose stable coronary artery disease.
Objective
The investigators want to investigate if a 3D-speckle-tracking is superior and more accurate in predicting hemodynamically significant coronary artery stenosis than predicted by 2D echocardiography? The reference variable for the hemodynamic significance of coronary artery stenosis is invasively measured by coronary flow reserve (CFR) in consideration of collateral flow (CFI).
Methods
This is a prospective observational study. The investigators will include 100 persons who are scheduled for an elective coronary angiography.
A regular 2D-stress echocardiography according to the international guidelines will be performed (incl. PLAX, SAX, 2CV, 4CV). The classification of regional wall motion abnormality is carried out according to the internationally recognized standards in 16 myocardial segments of the LV, with a grading of wall thickening (0 = dyskinetic, akinetic = 1, 2 = hypokinetic, 3 = normal). In addition, a 3D speckle tracking is performed after data transfer. To determine the functional relevance of any stenosis (reference method) a flow reserve in a maximum of two coronary arteries will be performed.
Test accuracy of 2D stress echocardiography and the new 3D method for detecting a significant stenosis (CFI \<2) are then compared.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Scheduled elective coronary angiography
- Age >/= 18 years
- Written informed consent
Exclusion Criteria
- Age < 18 years
- Acute coronary syndrome
- Unstable angina pectoris
- Coronary 3-vessel disease
- Left-main artery affected
- Situation after myocardial infarction
- Coronary anomaly
- Situation after coronary bypass
- Congenital heart disease
- Pacemaker
- Any contraindication concerning stress-echo
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All patients Stress-echocardiography Patients with a suspicion of coronary heart disease
- Primary Outcome Measures
Name Time Method Area Strain in the affected coronary artery stenosis myocardial segments (Reference: Coronary flow reserve CFR) After dobutamin-stress-echocardiography, PTCA will be performed within aprox.1-3hours Area Strain (%) by Echocardiography
- Secondary Outcome Measures
Name Time Method Area at Risk: Surface Area of site with reduced strain relative to the total LV-surface After dobutamin-stress-echocardiography, PTCA will be performed within aprox.1-3hours Size of infarcted area according to the Area Strain (in % of total LV-surface)
Trial Locations
- Locations (1)
Dept of Cardiology, Bern University Hospital
🇨ðŸ‡Bern, Switzerland