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

• Status: Completed
• Trial end date: 2017-10-23
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel S. Berman
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Regadenoson

Criteria

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.