Ischemic Heart Disease Clinical Trial
— PET/MR-POfficial title:
Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson
Verified date | May 2018 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective for this pilot study is to develop an optimized, clinically usable myocardial
PET-MR perfusion protocol and to determine which of all data potentially available should be
acquired for a clinical myocardial perfusion examination. Hypothesis: The hypothesis is that
high resolution, high sensitivity DCE MRI could replace the rest PET myocardial perfusion
imaging, significantly decreasing examination time and patient radiation dose while
maintaining the comprehensive reference-quality PET myocardial stress perfusion coverage.
The primary outcome will be comparison of diagnostic accuracy of each combination of imaging
to detect clinically significant coronary artery stenosis (≥70% diameter stenosis).
Status | Completed |
Enrollment | 16 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who have had a clinically ordered rest/regadenoson single-isotope SPECT-MPI study within 10 days prior to cardiac PET-MRI examination - Reversible perfusion abnormalities on SPECT imaging in at least 2 contiguous myocardial segments - Patients for whom standard of care coronary ICA is planned Exclusion Criteria: - An clinical event (ie; worsening angina pectoris or myocardial infarction) occuring after the SPECT-MPI and before the cardiac MRI examination - Myocardial revascularization occuring after the SPECT-MPI and before the cardiac MRI examination - Contraindications to MR imaging (pacemaker, brain aneurysm clips, shrapnel, etc.) - Renal insufficiency (GFR < 60 mL/min/1.73m2) - Allergy or other contraindication to gadolinium-based MR contrast agent - Second or third degree atrioventricular (AV) block - Active asthma - Seizures - Current hypotension (<100/60) - Current hypertension (>160/90) - Pregnancy - Breast feeding - Use of caffeine, nicotine or over the counter cold medicines within 12 hours of the cardiac PET-MRI examination - Use of the medication dipyridamole within 48 hrs of the cardiac PET-MRI examination |
Country | Name | City | State |
---|---|---|---|
United States | Center for Clinical Imaging Research at Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Astellas Pharma US, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic Accuracy of Cardiac PET/MRI Examination | The accuracy of the cardiac PET and cardiac MR examination components of the PET/MRI, and the accuracy of the combined PET/MR examination, for ischemic heart disease will be compared to the accuracy of cardiac SPECT in patients who have had ICA as "truth" or the reference standard. To assess the accuracy of an abbreviated PET/MR examination, an additional accuracy analysis was made using only the stress PET perfusion imaging and the MR LGE data sets. The accuracy of this combined data set was also determined with ICA as "truth" or the reference standard. Accuracy is calculated as % difference = (experimental - true) x 100%. | PET/MRI imaging was performed within 10 days after SPECT-MPI examination |
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