New Three-dimensional Methods of Analysis for the Detection of Coronary Artery Disease by Dobutamine Stress Echocardiography (3-DSE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02240745|
Recruitment Status : Unknown
Verified April 2016 by University Hospital Inselspital, Berne.
Recruitment status was: Recruiting
First Posted : September 16, 2014
Last Update Posted : April 15, 2016
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease Echocardiography, Stress||Other: Stress-echocardiography|
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.
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).
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||New Three-dimensional Methods of Analysis for the Detection of Coronary Artery Disease by Dobutamine Stress Echocardiography|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||November 2016|
Patients with a suspicion of coronary heart disease
Stress-echocardiography (incl dobutamin and atropin)
- Area Strain in the affected coronary artery stenosis myocardial segments (Reference: Coronary flow reserve CFR) [ Time Frame: After dobutamin-stress-echocardiography, PTCA will be performed within aprox.1-3hours ]Area Strain (%) by Echocardiography
- Area at Risk: Surface Area of site with reduced strain relative to the total LV-surface [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240745
|Contact: Stefano de Marchi, Senior Consultant||+41 31 632 21 firstname.lastname@example.org|
|Dept of Cardiology, Bern University Hospital||Recruiting|
|Bern, Switzerland, 3010|
|Contact: Stefano de Marchi, Senior consultant +41 31 632 2111 email@example.com|
|Contact: Reto Kurmann, Research fellow +41 31 632 2111 firstname.lastname@example.org|
|Principal Investigator: Stefano de Marchi, Dr. med.|
|Sub-Investigator: Reto Kurmann|
|Principal Investigator:||Stefano de Marchi, Senior consultant||Dept. of Cardiology, University Hospital of Bern, Bern|