Myocardial Perfusion Magnetic Resonance Imaging Using Regadenoson

Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881218
• Other study ID #: REGADENOSON.MRI.WUSTL
• Status: Completed
• Phase: Phase 0
• First received: April 13, 2009
• Last updated: April 8, 2012
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of use of regadenoson during cardiac perfusion MRI to visualize regions of myocardial ischemia as demonstrated on SPECT-MPI.		1 year	No