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Strain-Encoded Cardiac Magnetic Resonance Imaging for Dobutamine Stress Testing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758654
First Posted: September 25, 2008
Last Update Posted: March 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
G. Korosoglou, University of Heidelberg
September 23, 2008
September 25, 2008
March 30, 2012
January 2007
January 2011   (Final data collection date for primary outcome measure)
Detection of coronary artery disease (>50% diameter stenosis) by invasive angiography [ Time Frame: 3 weeks ]
Same as current
Complete list of historical versions of study NCT00758654 on ClinicalTrials.gov Archive Site
Long-term mortality and MACE [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
Strain-Encoded Cardiac Magnetic Resonance Imaging for Dobutamine Stress Testing
Strain-Encoded Cardiac Magnetic Resonance Imaging as an Adjunct for Dobutamine Stress Testing.
The purpose of this study is to compare the diagnostic value of SENC to that provided by conventional wall motion analysis for the detection of inducible ischemia during DS-MRI.High-dose dobutamine stress magnetic resonance imaging (DS-MRI) is safe and feasible for the diagnosis of coronary artery disease (CAD) in humans. However, the assessment of cine scans relies on the visual interpretation of regional wall motion, which is subjective. Recently, Strain-Encoded MRI (SENC) has been proposed for the direct color-coded visualization of myocardial strain.

The assessment of inducible regional wall motion abnormalities during high-dose dobutamine stress magnetic resonance imaging (DS-MRI) is an established clinical method with high diagnostic and prognostic value for the evaluation of patients with coronary artery disease (CAD). However, the assessment of cine images relies on the visual interpretation of regional wall motion, which is subjective, and objective approaches for the detection of inducible ischemia with DS-MRI are still lacking.

In our study Strain-Encoded-MRI (SENC) is used for the objective color-coded evaluation of regional myocardial strain during DS-MRI in patients with intermediate to high pretest probability for CAD. We anticipated that this technique would exhibit enhanced sensitivity for the detection of anatomically significant CAD compared to conventional wall motion reading, with invasive coronary angiography used as the standard reference.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Consecutive patients with suspected or known coronary artery disease and healthy volunteers serving as a contol group.
Coronary Artery Disease
Not Provided
  • 1
    Patients with suspected or known stable coronary artery disease
  • 2
    Healthy subjects as a control group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
January 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Suspected or known coronary artery disease

Exclusion Criteria:

  • General contraindication for a dobutamine stress or for an MRI examination
  • Age < 18 yrs
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00758654
MRI-021
No
Not Provided
Not Provided
G. Korosoglou, University of Heidelberg
Heidelberg University
Not Provided
Not Provided
Heidelberg University
March 2012