Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies

Daniel S. Berman

Status: Completed

Conditions: Coronary Artery Disease; CAD

Treatments: Device: Myocardial perfusion MRI; Drug: regadenoson; Drug: Optimark®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01949844

28466

Details and patient eligibility

About

This is a pilot study in a patient population with suspected coronary artery disease (CAD) as defined by the presence of a prior abnormal nuclear (PET/SPECT) myocardial perfusion scan. In this study design, PET/SPECT will serve as the comparative standard for presence of myocardial ischemia. We intend to determine the accuracy of an improved magnetic resonance imaging (MRI) technique for detection of myocardial ischemia in subjects with suspected CAD.

This is not a study to specifically evaluate the efficacy or safety of the drugs but rather the diagnostic performance of the improved cardiac MRI procedure.

Full description

A total of two imaging protocols will be used as "protocol options" in this study (only one of the protocols will be used for each enrolled subject): (1) "Two-day protocol," which involves MRI of subjects who have had a recent abnormal PET/SPECT study and includes an optional second-day visit; (2) "One-day protocol," which involves the subjects undergoing stress myocardial perfusion SPECT and MRI in the same day.

Two blinded readers will interpret MR and SPECT/PET studies by consensus to assess the presence of perfusion deficits at stress and rest.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically indicated nuclear myocardial perfusion (PET/SPECT) study with mild to moderate ischemia or prior myocardial infarction AND a visual scan interpretation of definitely abnormal AND no intervening revascularization since the prior study; or,
• Clinically stable individuals with suspected or known coronary artery disease on the basis of coronary angiography.

Exclusion criteria

• < 18 years of age
• Hypotension (systolic blood pressure <100 mm Hg)
• Significant non-coronary cardiac disease (e.g. severe valvular abnormality, significant cardiomyopathy, etc.)
• Persons unable to successfully pass MRI health and safety screening
• Persons whose renal function test does not meet CSMC standard of care MRI contrast protocol requirements (GFR <45 ml/min based on serum creatinine, age, gender, and ethnicity).
• Subjects with contraindications to or intolerance of regadenoson.
• Persons with an allergy to gadolinium-based contrast.
• Persons with a history of kidney or liver disease.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Suspected coronary artery disease (CAD)

Other group

Description:

This pilot study has a single arm/group of subjects with suspected CAD based on the following inclusion criteria: 1. Prior nuclear myocardial perfusion scan (PET/SPECT) with a visual interpretation of definitely abnormal, or prior myocardial infarction; or, 2. Clinically stable individuals with suspected coronary artery disease on the basis of coronary angiography. The study protocol involved only a myocardial perfusion MRI procedure for detection of ischemia (perfusion deficits) using an improved protocol with the administration of a vasodilator drug (Regadenoson/Lexiscan®) and gadolinium-based MRI contrast agent (Optimark®; dose: 0.2 mmol/kg). Lexiscan® was used off-label as a vasodilator drug during the MRI scan (0.4 mg/5mL) supplied by the manufacturer, Astellas Pharma U.S.

Treatment:

Drug: Optimark®

Drug: regadenoson

Device: Myocardial perfusion MRI