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

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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
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Echocardiography, Stress 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

Drug Information available for: Dobutamine

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 consecutive subjects referred to the Department of Cardiology for elective coronary angiography.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Stefano de Marchi, Senior Consultant +41 31 632 21 11 stefano.demarchi@insel.ch

Locations
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Switzerland
Dept of Cardiology, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Contact: Stefano de Marchi, Senior consultant    +41 31 632 2111    stefano.demarchi@insel.ch   
Contact: Reto Kurmann, Research fellow    +41 31 632 2111    reto.kurmann@insel.ch   
Principal Investigator: Stefano de Marchi, Dr. med.         
Sub-Investigator: Reto Kurmann         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Stefano de Marchi, Senior consultant Dept. of Cardiology, University Hospital of Bern, Bern
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, Sabaté 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, Rydén 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. Erratum in: Eur Heart J. 2014 Sep 1;35(33):2260-1.

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02240745    
Other Study ID Numbers: 039/14
SNCTP 0761 ( Other Identifier: KOFAM )
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Keywords provided by University Hospital Inselspital, Berne:
Echocardiography, Stress
Echocardiography, Three-Dimensional
Coronary Artery Disease
Fractional Flow Reserve, Myocardial
Coronary Circulation
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases