Skip to content

Myocardial Perfusion Magnetic Resonance Imaging Using Regadenoson

Feasibility of Detecting Myocardial Ischemia by First-pass Contrast MRI Using Regadenoson

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00881218
Enrollment
50
Registered
2009-04-15
Start date
2009-06-30
Completion date
2011-12-31
Last updated
2012-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Keywords

myocardial ischemia, perfusion imaging, cardiac MRI

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.

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.

Interventions

DRUGRegadenoson

Regadenoson 400 micrograms will be administered IV bolus via an antecubital cannula.

Sponsors

Astellas Pharma US, Inc.
CollaboratorINDUSTRY
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.)

Design outcomes

Primary

MeasureTime frame
Feasibility of use of regadenoson during cardiac perfusion MRI to visualize regions of myocardial ischemia as demonstrated on SPECT-MPI.1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026