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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016645-25 | EudraCT Number |
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The main purpose of this study is to compare myocardial perfusion imaging using Rubidium-82 PET with Tc-99m-MIBI SPET, in the evaluation of significant Coronary Artery Disease (CAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other | This is an Head to Head Comparison between Rubidium-82 PET and Tc-99m-MIBI SPET with CTA as gold standard. All the patients will undergo the three imaging protocols. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rubidium-82 | Drug | Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use |
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| Measure | Description | Time Frame |
|---|---|---|
| The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography) | The primary objective is to compare PET vs. SPET, with the primary outcome being the specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography). | Up to 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images. | Up to 2 days | |
| Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET. | Up to 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leon Menezes, Dr. | University College Hospital London NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Hospital London NHS Foundation Trust | London | London | NW1 2BU | United Kingdom |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000615479 | Rubidium-82 |
| D013670 | Sodium Pertechnetate Tc 99m |
| ID | Term |
|---|---|
| D017556 | Technetium Compounds |
| D007287 | Inorganic Chemicals |
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| Sestamibi. reconstitution with sodium pertechnetate (99mTc) | Drug | Maximum dose allowed per injection: 1000 MBq Intravenous Use |
|
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| Evaluate any difference in image quality, artefacts and interpretative confidence between Rubidium-82 PET and Tc-99m-MIBI SPET. | Up to 2 days |
| Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration. | Up to 2 days |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |