Back to resultsArtifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies
Primary Purpose
Coronary Artery Disease, CAD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
regadenoson
Optimark®
Myocardial perfusion MRI
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Artery Disease focused on measuring MRI, Magnetic Resonance Imaging, myocardial perfusion, myocardial perfusion imaging, Novel MRI Techniques
Eligibility 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.
Sites / Locations
- Cedars-Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Suspected coronary artery disease (CAD)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01949844
First Posted
September 11, 2013
Last Updated
August 16, 2018
Sponsor
Daniel S. Berman
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01949844
Brief Title
Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies
Official Title
Artifact-Free High-resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 16, 2014 (Actual)
Primary Completion Date
January 15, 2017 (Actual)
Study Completion Date
October 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel S. Berman
Collaborators
Astellas Pharma US, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, CAD
Keywords
MRI, Magnetic Resonance Imaging, myocardial perfusion, myocardial perfusion imaging, Novel MRI Techniques
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suspected coronary artery disease (CAD)
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
regadenoson
Other Intervention Name(s)
Lexiscan®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Optimark®
Other Intervention Name(s)
gadoversetamide, gadolinium, MRI contrast agent, gadolinium contrast
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Myocardial perfusion MRI
Other Intervention Name(s)
magnetic resonance imaging, ischemia, cardiac blood flow, perfusion
Primary Outcome Measure Information:
Title
Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images
Description
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.
Time Frame
Baseline only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel S Berman, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
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Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies
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