CAD, Coronary Artery Disease
Conditions
Keywords
MRI, Magnetic Resonance Imaging, myocardial perfusion, myocardial perfusion imaging, Novel MRI Techniques
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.
Interventions
DRUGregadenoson
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.
DRUGOptimark®
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.
DEVICEMyocardial perfusion MRI
Sponsors
Astellas Pharma US, Inc.
Daniel S. Berman
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| 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. | 44 |
| Total | 88 |
Baseline characteristics
| Characteristic | Suspected Coronary Artery Disease (CAD) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 23 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 44 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
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.
Time frame: Baseline only
Population: Patients who did not have diagnostically interpretable MRI data were not analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Suspected Coronary Artery Disease (CAD) | Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images | diagnostic sensitivity | 95 percentage of true cases |
| Suspected Coronary Artery Disease (CAD) | Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images | diagnostic specificity | 94 percentage of true cases |