Trial Outcomes & Findings for Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies (NCT NCT01949844)
NCT ID: NCT01949844
Last Updated: 2018-08-20
Results Overview
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.
COMPLETED
NA
44 participants
Baseline only
2018-08-20
Participant Flow
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.
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.
Participant milestones
| Measure |
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:
1. Prior nuclear myocardial perfusion (PET/SPECT) scan 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.
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.
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|---|---|
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Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
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44
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies
Baseline characteristics by cohort
| Measure |
Suspected Coronary Artery Disease (CAD)
n=44 Count of Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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23 Participants
n=5 Participants
|
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Age, Continuous
|
65 years
STANDARD_DEVIATION 11 • n=44 Count of Participants
|
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline onlyPopulation: Patients who did not have diagnostically interpretable MRI data were not analyzed.
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.
Outcome measures
| Measure |
Suspected Coronary Artery Disease (CAD)
n=38 Participants
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.
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|---|---|
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Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images
diagnostic sensitivity
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95 percentage of true cases
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Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images
diagnostic specificity
|
94 percentage of true cases
|
Adverse Events
Suspected Coronary Artery Disease (CAD)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Behzad Sharif, Assistant Professor
Cedars-Sinai Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place