New Three-dimensional Methods of Analysis for the Detection of Coronary Artery Disease by Dobutamine Stress Echocardiography (3-DSE)

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Coronary Artery Disease; Echocardiography, Stress

Treatments: Other: Stress-echocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT02240745

039/14

SNCTP 0761 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

100 participants in 1 patient group

All patients

Description:

Patients with a suspicion of coronary heart disease

Treatment:

Other: Stress-echocardiography