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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; CAD
• Interventions: Drug: regadenoson; Drug: Optimark®; Device: Myocardial perfusion MRI

• Registration Number: NCT01949844
• Lead Sponsor: Daniel S. Berman

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-20
• Study First Posted: 2013-09-25
• Study Start: 2014-05-16
• Primary Completion: 2017-01-15
• Study Completion: 2017-10-23
• Results First Submitted: 2018-05-21
• Results First Submitted QC: 2018-05-21
• Results First Posted: 2018-06-25
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Suspected coronary artery disease (CAD)	Optimark®	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.
Suspected coronary artery disease (CAD)	Myocardial perfusion MRI	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.
Suspected coronary artery disease (CAD)	regadenoson	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images	Baseline only	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.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States