Ischemic Heart Disease
Conditions
Keywords
PET MR myocardial perfusion imaging
Brief summary
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).
Detailed description
Simultaneous acquisition PET-MRI is a new technology that has the potential to significantly impact diagnostic patient care. It combines high signal resolution MRI anatomic imaging and PET biological measurements, with the added benefit of radiation dose reduction in comparison to PET-CT. As the incidence of false positive SPECT-MPI studies secondary to attenuation artifact is relatively high and MRI coverage of the left ventricular myocardium is limited, it is likely that one of the immediate applications of PET-MRI technology is myocardial ischemia assessment. PET has long been considered the noninvasive reference standard for myocardial perfusion. However, delayed contrast enhanced (DCE) MRI is very sensitive for infarct detection. Indeed, both PET and MR imaging have the potential to provide comprehensive whole heart ischemia and infarct detection. PET-MR technology, with its ability to obtain simultaneous perfusion information via both PET and MRI, has the potential to obtain multiple, possibly redundant, data sets. On the other hand, it also has the potential to combine the best of both techniques to provide a highly robust examination that is both shorter and of lower radiation dose than the standard myocardial PET perfusion examination. Optimization of a protocol is necessary to develop a comprehensive protocol without redundancy. Because of its single injection capability, regadenoson is ideally suited to a protocol that will assess and employ dual-modality myocardial perfusion data collection. It is expected that the best candidates for PET-MR myocardial perfusion imaging will likely be a) patients whose body habitus suggests that their SPECT-MPI examination would be limited by attenuation artifact -- women with large breasts and patients (usually men) with abdominal obesity and/or b) patients who may have a smaller region of ischemia that might be missed on an MRI examinations with limited perfusion coverage.
Interventions
DRUGRegadenoson
Regadenoson 400 micrograms will be administered in a single IV bolus (\<10 seconds) via an antecubital cannula and followed by 5 mL of saline flush. 10-20 seconds after the regadenoson is administered, 10 mCi of 13N-ammonia as a bolus, and 0.075 mmol/Kg of gadobenate dimeglumine MR contrast agent at a rate of 5 mL/sec followed by a 15 mL normal saline flush will be administered simultaneous, each into an antecubital vein, and a 15 min list-mode PET acquisition will be acquired simultaneously with the MR perfusion imaging.
Sponsors
Astellas Pharma US, Inc.
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy of Cardiac PET/MRI Examination | PET/MRI imaging was performed within 10 days after SPECT-MPI 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%. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Group Assignment - Imaging All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson.
Regadenoson: Regadenoson 400 micrograms will be administered in a single IV bolus (\<10 seconds) via an antecubital cannula and followed by 5 mL of saline flush. 10-20 seconds after the regadenoson is administered, 10 mCi of 13N-ammonia as a bolus, and 0.075 mmol/Kg of gadobenate dimeglumine MR contrast agent at a rate of 5 mL/sec followed by a 15 mL normal saline flush will be administered simultaneous, each into an antecubital vein, and a 15 min list-mode PET acquisition will be acquired simultaneously with the MR perfusion imaging. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Single Group Assignment - Imaging |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 12.4 |
| Positive cardiac SPECT stress test (2 contiguous segments) | 16 Participants |
| Scheduled to undergo ICA | 16 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
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%.
Time frame: PET/MRI imaging was performed within 10 days after SPECT-MPI examination
Population: Patients who completed the full PET-MR myocardial perfusion examination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Group Assignment - Imaging | Diagnostic Accuracy of Cardiac PET/MRI Examination | SPECT Accuracy | 50 percentage |
| Single Group Assignment - Imaging | Diagnostic Accuracy of Cardiac PET/MRI Examination | MR Accuracy | 64 percentage |
| Single Group Assignment - Imaging | Diagnostic Accuracy of Cardiac PET/MRI Examination | PET Accuracy | 61 percentage |
| Single Group Assignment - Imaging | Diagnostic Accuracy of Cardiac PET/MRI Examination | Combined PET/MR Accuracy | 64 percentage |
| Single Group Assignment - Imaging | Diagnostic Accuracy of Cardiac PET/MRI Examination | Abbreviated PET/MR | 64 percentage |
Comparison: Significance testing between the diagnostic accuracy of SPECT and PET, and SPECT and MR, and SPECT and PET/MR was performed by using chi square test. A P value \< 0.05 was considered significant.p-value: 0.35Chi-squared