Clinical trial NCT00758654: Strain-Encoded Cardiac Magnetic Resonance Imaging for Dobutamine Stress Testing
Official title: Strain-Encoded Cardiac Magnetic Resonance Imaging as an Adjunct for Dobutamine Stress Testing.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: myocardial strain
Strain-Encoded MRI
dobutamine stress MRI
ischemia
strain rate reserve
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with suspected or known coronary artery disease and healthy volunteers serving as a contol group.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Suspected or known coronary artery disease

Exclusion Criteria:

* General contraindication for a dobutamine stress or for an MRI examination
* Age \< 18 yrs

Primary outcomes:
measure: Detection of coronary artery disease (>50% diameter stenosis) by invasive angiography
timeFrame: 3 weeks
Secondary outcomes:
measure: Long-term mortality and MACE
timeFrame: 2 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg, Department of Cardiology
Study officials:
References:
citation: Korosoglou G, Gitsioudis G, Voss A, Lehrke S, Riedle N, Buss SJ, Zugck C, Giannitsis E, Osman NF, Katus HA. Strain-encoded cardiac magnetic resonance during high-dose dobutamine stress testing for the estimation of cardiac outcomes: comparison to clinical parameters and conventional wall motion readings. J Am Coll Cardiol. 2011 Sep 6;58(11):1140-9. doi: 10.1016/j.jacc.2011.03.063.
citation: Korosoglou G, Lehrke S, Wochele A, Hoerig B, Lossnitzer D, Steen H, Giannitsis E, Osman NF, Katus HA. Strain-encoded CMR for the detection of inducible ischemia during intermediate stress. JACC Cardiovasc Imaging. 2010 Apr;3(4):361-71. doi: 10.1016/j.jcmg.2009.11.015.