Efficiency and Outcomes of Stress-Only Anger and D-SPECT Stress-Only SPECT MPI

Study Overview
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Brief Summary
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The purpose of this study is to compare clinical efficiency and patient outcomes using ultra low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT.

Official Title
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Rapid-Acquisition Low-Dosimetry Tc-99m Stress-Only Myocardial Perfusion SPECT on the Spectrum Dynamics System: Comparison of Efficiency and Outcomes With Stress-Only Anger SPECT

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI < 35 kg/m2 LVEF > 40% Exercise stress Elective out-patients No known CAD (>50%) by catheterization No history of prior myocardial infarction Exclusion Criteria: LBBB Pacemaker Atrial Fibrillation Frequent PAC's or PVC's Inability to achieve at least 6 minutes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stress Only SPECT MPI with Anger Camera<br>Patients undergoing clinically-indicated stress-only sestamibi studies who are imaged on the traditional Anger camera | |
| Stress Only SPECT MPI with SD Camera<br>Patients undergoing clinically-indicated stress-only sestamibi studies who are imaged on the Spectrum Dynamics camera system. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Failure | Diagnostic failure is defined by a composite of need for additional downstream testing (anger SPECT, MPI PET, stress echocardiography or coronary CT angiography) within 30 days or a coronary angiogram with no stenoses greater than or equal to 50% severity using quantitative coronary angiography. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Necessity to proceed to a rest image | The first of 4 secondary end-points is the need to proceed to a rest image. | 30 days | 
| Necessity for additional downstream testing | The second of four secondary endpoints the need for additional downstream testing within 30 days to address the same clincial reason for the innitial referral for stress-onoly imaging, in the absence of any changes in clincial status between tests. | 30 days | 
| Coronary Angiography | The third of four secondary end-points is the occurrence of coronary angiography with no stenoses greater than or equal to 50% severity using quantitative coronary angiography. | 60 to 90 days | 
| Determine optimal performance of the Spectrum Dynamics camera system for stress only imaging | The fourth of four secondary endpoints is to determine optimal performance of the Spectrum Dynamics camera system for stress only imaging: upright imaging alone, supine imaging alone, or both in terms of primary and secondary endpoints | 60 to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MPI, SPECT, Stress-Only, Spectrum Dynamics Camera, Anger