- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00881218
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Regadenoson 400 micrograms will be administered IV bolus via an antecubital cannula.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Feasibility of use of regadenoson during cardiac perfusion MRI to visualize regions of myocardial ischemia as demonstrated on SPECT-MPI.
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Pamela K. Woodard, M.D., Washington University School of Medicine
Publications and helpful links
General Publications
- Aljaroudi W, Hermann D, Hage F, Heo J, Iskandrian AE. Safety of regadenoson in patients with end-stage renal disease. Am J Cardiol. 2010 Jan 1;105(1):133-5. doi: 10.1016/j.amjcard.2009.08.663. Epub 2009 Nov 18.
- Iskandrian AE, Bateman TM, Belardinelli L, Blackburn B, Cerqueira MD, Hendel RC, Lieu H, Mahmarian JJ, Olmsted A, Underwood SR, Vitola J, Wang W; ADVANCE MPI Investigators. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol. 2007 Sep-Oct;14(5):645-58. doi: 10.1016/j.nuclcard.2007.06.114.
- Cerqueira MD, Nguyen P, Staehr P, Underwood SR, Iskandrian AE; ADVANCE-MPI Trial Investigators. Effects of age, gender, obesity, and diabetes on the efficacy and safety of the selective A2A agonist regadenoson versus adenosine in myocardial perfusion imaging integrated ADVANCE-MPI trial results. JACC Cardiovasc Imaging. 2008 May;1(3):307-16. doi: 10.1016/j.jcmg.2008.02.003.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Purinergic Agents
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Adenosine A2 Receptor Agonists
- Regadenoson
Other Study ID Numbers
- REGADENOSON.MRI.WUSTL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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