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The study is designed to determine whether a dual isotope protocol is equivalent to a single isotope in the diagnosis of myocardial ischemia and infarction using MYOVIEW SPECT imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Thallous Chloride T1-201 |
|
| 2 | Active Comparator | Technetium Tc99m Tetrofosmin injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technetium Tc99m Tetrofosmin injections | Drug | Single Isotope: be 555 to 888 MBq (15 to 24 mCi) MYOVIEW at Rest/i.v./bolus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic results ("normal" versus "abnormal") of the dual-isotope and single isotope myocardial SPECT examinations will be compared for equivalence on a subject level for the Uninformed and Informed Analysis Groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre Mueller-York | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
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| Thallous Chloride T1-201 | Drug | Myoview SPECT Imaging |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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