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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

Tracking Information
First Submitted Date September 11, 2014
First Posted Date September 16, 2014
Last Update Posted Date April 15, 2016
Study Start Date November 2014
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 15, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 15, 2014)
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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title New Three-dimensional Methods of Analysis for the Detection of Coronary Artery Disease by Dobutamine Stress Echocardiography
Official Title New Three-dimensional Methods of Analysis for the Detection of Coronary Artery Disease by Dobutamine Stress Echocardiography
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 100 consecutive subjects referred to the Department of Cardiology for elective coronary angiography.
Condition
  • Coronary Artery Disease
  • Echocardiography, Stress
Intervention Other: Stress-echocardiography
Stress-echocardiography (incl dobutamin and atropin)
Study Groups/Cohorts All patients
Patients with a suspicion of coronary heart disease
Intervention: Other: Stress-echocardiography
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 15, 2014)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02240745
Other Study ID Numbers 039/14
SNCTP 0761 ( Other Identifier: KOFAM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor University Hospital Inselspital, Berne
Collaborators Not Provided
Investigators
Principal Investigator: Stefano de Marchi, Senior consultant Dept. of Cardiology, University Hospital of Bern, Bern
PRS Account University Hospital Inselspital, Berne
Verification Date April 2016