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Completed

NCT Number: NCT00881218

Myocardial Perfusion Magnetic Resonance Imaging 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Regadenoson

Drug

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

Other names: Lexiscan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Astellas Pharma US, Inc.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2009
Registry last updated
Apr 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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