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Myocardial Perfusion Magnetic Resonance Imaging Using Regadenoson

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ClinicalTrials.gov Identifier: NCT00881218
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : April 10, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

This is a pilot study to determine whether the drug regadenoson can be used during magnetic resonance imaging to assess regions of poor blood flow to the heart.

The hypothesis of this study is that a single injection of regadenoson could be used instead of a standard adenosine infusion to produce coronary vasodilatation and demonstrate myocardial ischemia during first-pass perfusion cardiac MRI.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Drug: Regadenoson Early Phase 1

Detailed Description:

This is a pilot study that proposes to assess the feasibility of using regadenoson (Lexiscan, Astellas), a recently FDA approved A2A receptor agonist, as the stress perfusion agent in cardiac MRI perfusion examinations. While regadenoson has been approved by the FDA, it has not been approved for the specific indications of use 1) during the simultaneous intravenous administration of a gadolinium-based contrast agent, or 2) during magnetic resonance imaging (MRI).

Because this agent can be given intravenously in a single 400 microgram bolus, rather than in an infusion, this agent may be easier to administer than adenosine during an MRI examination.

The objectives for this pilot study are: 1) To demonstrate the feasibility of using regadenoson during cardiac perfusion MRI to visualize known regions of myocardial ischemia as demonstrated on SPECT-MPI and 2) To describe a cardiac perfusion MRI protocol using regadenoson that would have the potential to be used clinically.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Feasibility of Detecting Myocardial Ischemia by First-pass Contrast MRI Using Regadenoson
Study Start Date : June 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Regadenoson
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Regadenoson CMR
Images in the cardiac short axis will be obtained using a gradient recalled echo sequence, TR 2.3 msec/TE 1.1 msec, 80*256 matrix, slice thickness 10 mm. Images will be obtained during power injection of 0.075 mmol/Kg of a conventional gadolinium based MR contrast agent at a rate of 5 mL/sec followed by a 15 mL saline flush into an antecubital vein. Perfusion imaging will be performed at stress and rest. Stress: Regadenoson 400 mcg will be administered IV bolus via an antecubital cannula. Immediately after injection, MR scanning will begin and contrast will be given. Rest: After 10 minutes, rest imaging will be performed identically, but without regadenoson injection. To identify late enhancement of myocardial tissue inversion recovery prepared images will be obtained.
Drug: Regadenoson
Regadenoson 400 micrograms will be administered IV bolus via an antecubital cannula.
Other Name: Lexiscan

Outcome Measures

Primary Outcome Measures :
  1. Feasibility of use of regadenoson during cardiac perfusion MRI to visualize regions of myocardial ischemia as demonstrated on SPECT-MPI. [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • reversible perfusion abnormalities on a clinically ordered rest/adenosine dual-isotope SPECT-MPI in at least 2 contiguous myocardial segments (per 17-segment model)

Exclusion Criteria:

  • myocardial infarction, myocardial revascularization procedure or progression in angina occuring after the SPECT-MPI examination
  • pregnancy
  • gadolinium-based MR contrast allergy
  • glomerular filtration rate (GFR) > 60 mL/min/1.73 m2
  • contraindications to MR imaging (pacemaker, brain aneurysm clips, schrapnel, etc.)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881218

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Astellas Pharma US, Inc.
Principal Investigator: Pamela K. Woodard, M.D. Washington University School of Medicine
More Information

Responsible Party: Pamela Woodard, MD, M.D., FACR, FAHA, FCCP, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00881218     History of Changes
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012

Keywords provided by Pamela Woodard, MD, Washington University School of Medicine:
myocardial ischemia, perfusion imaging, cardiac MRI

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs