Strain-Encoded Cardiac Magnetic Resonance Imaging for Dobutamine Stress Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
G. Korosoglou, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00758654
First received: September 23, 2008
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Strain-Encoded Cardiac Magnetic Resonance Imaging as an Adjunct for Dobutamine Stress Testing.

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Detection of coronary artery disease (>50% diameter stenosis) by invasive angiography [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Long-term mortality and MACE [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 320
Study Start Date: January 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with suspected or known stable coronary artery disease
2
Healthy subjects as a control group

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Consecutive patients with suspected or known coronary artery disease and healthy volunteers serving as a contol group.

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00758654

Locations
Germany
University of Heidelberg, Department of Cardiology
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
  More Information

No publications provided by Heidelberg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: G. Korosoglou, Prof. Dr., University of Heidelberg
ClinicalTrials.gov Identifier: NCT00758654     History of Changes
Other Study ID Numbers: MRI-021
Study First Received: September 23, 2008
Last Updated: March 28, 2012
Health Authority: Germany: Ethics Commission, University of Heidelberg.

Keywords provided by Heidelberg University:
myocardial strain
Strain-Encoded MRI
dobutamine stress MRI
ischemia
strain rate reserve

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dobutamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on October 01, 2014