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
  Purpose

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 Intervention Phase
Ischemic Heart Disease
Drug: Regadenoson
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Feasibility of Detecting Myocardial Ischemia by First-pass Contrast MRI Using Regadenoson

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881218

Locations
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.
Investigators
Principal Investigator: Pamela K. Woodard, M.D. Washington University School of Medicine
  More Information

Publications:
Responsible Party: Pamela Woodard, MD, M.D., FACR, FAHA, FCCP, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00881218     History of Changes
Other Study ID Numbers: REGADENOSON.MRI.WUSTL
Study First Received: April 13, 2009
Last Updated: April 8, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014