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Exercise Stress CMR Comparison Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jennifer Dickerson, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01504269
First received: January 3, 2012
Last updated: March 28, 2016
Last verified: March 2016
History of Changes

January 3, 2012
March 28, 2016
August 2007
December 2015   (final data collection date for primary outcome measure)
Diagnosis of coronary artery disease [ Time Frame: baseline ] [ Designated as safety issue: No ]
Cardiac MRI with the diagnostic information provided by exercise stress could result in a new, more accurate modality for diagnosing and evaluating coronary artery disease.
Same as current
Complete list of historical versions of study NCT01504269 on ClinicalTrials.gov Archive Site
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Exercise Stress CMR Comparison Study
Comparison of Exercise MRI and Exercise Nuclear Scintigraphy in Patients With Suspected Coronary Artery Disease.

This study is being done to compare standard nuclear exercise stress testing to exercise stress magnetic resonance imaging (MRI). The investigators have successfully shown that exercise MRI works well in healthy volunteers, and the next step is to test if it works as well as nuclear stress testing in patients with known or suspected heart disease.

MRIs offers superior image quality compared to echocardiography and nuclear imaging, and have the ability to image both function and perfusion. Combining the superior image quality of Cardiac MRI with the diagnostic information provided by exercise stress could result in a new, more accurate modality for diagnosing and evaluating coronary artery disease.
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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
Other: Diagnostic Cardiac Imaging
Cardiac Magnetic Resonance (CMR) offers superior image quality compared to echocardiography and nuclear imaging, and the ability to image both function and perfusion. Combining the superior image quality of CMR with the diagnostic information provided by exercise stress could result in a new, more accurate modality for diagnosing and evaluating coronary artery disease. This project is expected to show that CMR is at least equivalent to nuclear stress imaging and could potentially replace it in many instances, eliminating the need for radioisotope administration and the associated exposure of patients to ionizing radiation.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
227
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December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • any patient referred for stress SPECT
  • known or suspected ischemic heart disease
  • ability to perform adequate treadmill stress

Exclusion Criteria:

  • any contraindication to MRI (e.g. ferromagnetic foreign body, cerebral aneurysm clip, pacemaker/ICD, severe claustrophobia)
  • renal insufficiency (GFR <40)
  • known allergy to gadolinium-based contrast or iodinated contrast (because of the research CTA in patients not referred for cath after 2 weeks)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01504269
2007H0132
Yes
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Jennifer Dickerson, The Ohio State University
Jennifer Dickerson
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Principal Investigator: Jennifer Dickerson, MD Ohio State University
Ohio State University
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP