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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected coronary artery disease (CAD) | Other | This pilot study has a single arm/group of subjects with suspected CAD based on the following inclusion criteria:
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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| regadenoson | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel S Berman, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
This pilot study did not involve evaluation of the efficacy of a drug but rather the diagnostic performance of an improved cardiac magnetic resonance imaging (MRI) technique for detection of myocardial ischemia (presence of perfusion deficits) in subjects with suspected coronary artery disease.
A total of 44 subjects with suspected coronary artery disease defined based on prior abnormal nuclear myocardial perfusion (PET/SPECT) scan or prior abnormal coronary angiogram were recruited at Cedars-Sinai Medical Center (CSMC) in Los Angeles, CA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Suspected Coronary Artery Disease (CAD) | This pilot study involved a single arm/group of subjects with suspected CAD who all underwent cardiac magnetic resonance imaging (MRI) based on the following inclusion criteria:
Study Protocol: MRI for detection of perfusion deficits using an improved technique with the administration of a vasodilator drug (Regadenoson) and gadolinium-based MRI contrast agent (with standard dose of 0.2 mmol/kg). Vasodilator drug (Regadenoson) used in the study: Lexiscan® (FDA-issued IND# 119898) was used off-label as a vasodilator drug during the cardiac MRI scan as prescribed in the package insert (0.4 mg/5mL bolus followed by saline flush) supplied by the manufacturer, Astellas Pharma U.S., in single-use pre-filled syringes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Suspected Coronary Artery Disease (CAD) | This pilot study involved a single arm/group of subjects with suspected CAD who were recruited to undergo an improved cardiac magnetic resonance imaging (MRI) protocol with vasodilator stress (Regadenoson) for detection of myocardial perfusion defects. All subjects were recruited based on the following inclusion criteria: (a) prior nuclear myocardial perfusion (PET/SPECT) scan with a visual interpretation of definitely abnormal, or prior myocardial infarction; or, (b) clinically stable individuals with suspected coronary artery disease on the basis of invasive or noninvasive coronary angiography. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients who did not have diagnostically interpretable MRI data were not analyzed. | Posted | Number | percentage of true cases | Baseline only |
|
Duration of the visit to the medical center for undergoing the cardiac magnetic resonance imaging study (1 day).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Suspected Coronary Artery Disease (CAD) | This pilot study involved a single arm/group of subjects with suspected CAD who were recruited to undergo an improved cardiac magnetic resonance imaging (MRI) protocol with vasodilator stress (Regadenoson) for detection of myocardial perfusion defects. All subjects were recruited based on the following inclusion criteria: (a) prior nuclear myocardial perfusion scan with a visual interpretation of definitely abnormal, or prior myocardial infarction; or, (b) clinically stable individuals with suspected coronary artery disease on the basis of invasive or noninvasive coronary angiography. |
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This pilot study did not have a control/placebo arm and did not involve evaluation of the efficacy of a drug but rather the performance of an improved magnetic resonance imaging (MRI) technique with reduced image artifacts.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Behzad Sharif, Assistant Professor | Cedars-Sinai Medical Center | 310-423-7758 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C430916 | regadenoson |
| C112666 | gadoversetamide |
| D005682 | Gadolinium |
| C120577 | gadolinium compound P760 |
| D008279 | Magnetic Resonance Imaging |
| D010477 | Perfusion |
| ID | Term |
|---|---|
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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| Optimark® | Drug | 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. |
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| Myocardial perfusion MRI | Device |
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| Count of Participants |
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| Participants |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years | Count of Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | Participants |
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| 0 |
| 44 |
| 0 |
| 44 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D008670 |
| Metals |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |