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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Echocardiography, Stress
• Intervention / Treatment: Other: Stress-echocardiography

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Dept of Cardiology, Bern University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

100 consecutive subjects referred to the Department of Cardiology for elective coronary angiography.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patients; Patients with a suspicion of coronary heart disease	Other: Stress-echocardiography; Stress-echocardiography (incl dobutamin and atropin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Strain in the affected coronary artery stenosis myocardial segments (Reference: Coronary flow reserve CFR)	Area Strain (%) by Echocardiography	After dobutamin-stress-echocardiography, PTCA will be performed within aprox.1-3hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area at Risk: Surface Area of site with reduced strain relative to the total LV-surface	Size of infarcted area according to the Area Strain (in % of total LV-surface)	After dobutamin-stress-echocardiography, PTCA will be performed within aprox.1-3hours

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Stefano de Marchi, Senior consultant, Dept. of Cardiology, University Hospital of Bern, Bern

Publications and helpful links

General Publications

• Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available. Erratum In: Eur Heart J. 2014 Sep 1;35(33):2260-1.
• Doucette JW, Corl PD, Payne HM, Flynn AE, Goto M, Nassi M, Segal J. Validation of a Doppler guide wire for intravascular measurement of coronary artery flow velocity. Circulation. 1992 May;85(5):1899-911. doi: 10.1161/01.cir.85.5.1899.
• Traupe T, Gloekler S, de Marchi SF, Werner GS, Seiler C. Assessment of the human coronary collateral circulation. Circulation. 2010 Sep 21;122(12):1210-20. doi: 10.1161/CIRCULATIONAHA.109.930651. No abstract available.
• Meuwissen M, Siebes M, Chamuleau SA, Tijssen JG, Spaan JA, Piek JJ. Intracoronary pressure and flow velocity for hemodynamic evaluation of coronary stenoses. Expert Rev Cardiovasc Ther. 2003 Sep;1(3):471-9. doi: 10.1586/14779072.1.3.471.
• Varga A, Garcia MA, Picano E; International Stress Echo Complication Registry. Safety of stress echocardiography (from the International Stress Echo Complication Registry). Am J Cardiol. 2006 Aug 15;98(4):541-3. doi: 10.1016/j.amjcard.2006.02.064. Epub 2006 Jun 28.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2014
• Primary Completion (Actual): November 30, 2016
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: September 11, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimate): September 16, 2014

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Fractional Flow Reserve, Myocardial; Coronary Circulation; Echocardiography, Stress; Echocardiography, Three-Dimensional
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 039/14; SNCTP 0761 (Other Identifier: KOFAM)