Myocardial Perfusion Magnetic Resonance Imaging Using Regadenoson

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Pamela Woodard, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00881218
First received: April 13, 2009
Last updated: April 8, 2012
Last verified: April 2012

April 13, 2009
April 8, 2012
June 2009
December 2011   (final data collection date for primary outcome measure)
Feasibility of use of regadenoson during cardiac perfusion MRI to visualize regions of myocardial ischemia as demonstrated on SPECT-MPI. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00881218 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Myocardial Perfusion Magnetic Resonance Imaging Using Regadenoson
Feasibility of Detecting Myocardial Ischemia by First-pass Contrast MRI Using Regadenoson

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.

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.

Interventional
Phase 0
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Ischemic Heart Disease
Drug: Regadenoson
Regadenoson 400 micrograms will be administered IV bolus via an antecubital cannula.
Other Name: Lexiscan
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.
Intervention: Drug: Regadenoson

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2011
December 2011   (final data collection date for primary outcome measure)

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.)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00881218
REGADENOSON.MRI.WUSTL
Yes
Pamela Woodard, MD, Washington University School of Medicine
Washington University School of Medicine
Astellas Pharma US, Inc.
Principal Investigator: Pamela K. Woodard, M.D. Washington University School of Medicine
Washington University School of Medicine
April 2012

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