Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/22/2018 |
| Start Date: | May 16, 2014 |
| End Date: | October 23, 2017 |
Artifact-Free High-resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies
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.
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.
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.
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.
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Daniel S Berman, MD
Phone: 310-423-7758
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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