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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Artifact-Free High-resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies

Conditions
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CAD, Coronary Artery Disease

Intervention / Treatment
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* Drug: regadenoson
* Drug: Optimark®
* Device: Myocardial perfusion MRI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Suspected coronary artery disease (CAD)<br>This pilot study has a single arm/group of subjects with suspected CAD based on the following inclusion criteria: Prior nuclear myocardial perfusion scan (PET/SPECT) with a visual interpretation of definitely abnormal, or prior myocardial infarction; or, 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. | Drug: regadenoson<br>* Lexiscan® is being used off-label. The FDA Issued IND # is 119898. For the cardiac MRI, Lexiscan® will be used at the same dosage and administration as prescribed in the package insert - 5 mL (0.4 mg regadenoson) as packaged and supplied by the manufacturer, Astellas Pharma U.S., in single-use pre-filled syringes administered by rapid intravenous injection, followed immediately by saline flush.<br>* Other names: Lexiscan®;Drug: Optimark®<br>* For the cardiac MR, the contrast agent, Optimark® is administered as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual injection.<br>* Other names: gadolinium contrast;Device: Myocardial perfusion MRI<br> <br> * Other names: perfusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images | In this study, the approach is to use nuclear myocardial perfusion (prior PET/SPECT scans for the enrolled patients) as the comparative standard for detection of myocardial ischemia (presence of perfusion deficits). Using this approach, the acquired MR images will be analyzed to determine the diagnostic performance (specificity and sensitivity) of the improved MRI technique for detection of myocardial perfusion deficits. | Baseline only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Magnetic Resonance Imaging, myocardial perfusion, myocardial perfusion imaging, Novel MRI Techniques