Myocardial Perfusion Magnetic Resonance Imaging Using Regadenoson

The Washington University

Status and phase: Completed; Early Phase 1

Conditions: Ischemic Heart Disease

Treatments: Drug: Regadenoson

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00881218

REGADENOSON.MRI.WUSTL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

50 participants in 1 patient group

Regadenoson CMR

Experimental group

Description:

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.

Treatment:

Drug: Regadenoson