New Three-dimensional Methods of Analysis for the Detection of Coronary Artery Disease by Dobutamine Stress Echocardiography

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Echocardiography, Stress Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Cardiology, Bern University Hospital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Stress-echocardiography

Other

Stress-echocardiography (incl dobutamin and atropin)

Primary outcomes

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

Secondary outcomes

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)

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Acronym: 3-DSE

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Sep 16, 2014
Registry last updated: Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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