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Exercise Stress CMR Comparison Study

This study is currently recruiting participants.
Verified May 2013 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Jennifer Dickerson, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01504269
First received: January 3, 2012
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Disease
 Other: Diagnostic Cardiac Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Exercise MRI and Exercise Nuclear Scintigraphy in Patients With Suspected Coronary Artery Disease.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 333
Study Start Date: August 2007
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504269

Contacts
Contact: Debbie Scandling, B.S. 614-293-2098 Debbie.scandling@osumc.edu

Locations
United States, Ohio
Ross Heart Hospital Recruiting
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Jennifer Dickerson
Investigators
Principal Investigator: Jennifer Dickerson, MD Ohio State University
  More Information

No publications provided

Responsible Party: Jennifer Dickerson, Assistant Professor-Clinical, The Ohio State University
ClinicalTrials.gov Identifier: NCT01504269     History of Changes
Other Study ID Numbers: 2007H0132
Study First Received: January 3, 2012
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013