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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
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Researchers hope that this new non-invasive multi-detector scanner (DSCT) will provide diagnostic information comparable to the combination of traditional SPECT (for function and blood flow) and CT imaging (for a precise anatomical view).
The DSCT scanner is able to assess cardiac blood flow (myocardial perfusion) at the same time as coronary anatomy. The results derived from these scans will be compared to standard SPECT imaging.
To further evaluate obstruction in the coronary arteries, physicians may refer for an invasive Coronary Angiogram, the current gold standard for diagnosis of Coronary Artery Disease (CAD). By validating the DSCT scanner as a system with which to assess the extent of obstruction in the coronary arteries, physicians may be able to lessen the occurrence of an invasive exam.
Procedures: Each pilot anticipates enrolling 20 subjects.
Pilot 1: Clinical Follow-up Rest/Stress Adeno-SPECT and Research Stress /Rest Adeno-DSCT obtained in the same patient during the same period of stress testing
Pilot 2: Research Stress/ Rest Adeno-DSCT obtained within 30 days of initial positive SPECT finding
Both pilot studies will relate results to subject history, ECG and cardiac angiogram, if available
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Source Multidetector CT (DSCT) w/ Adenosine enhancement | Radiation | Somatom Definition Dual Source CT Scanner Stress/Rest Image scan using weight based CT contrast dye |
|
| Measure | Description | Time Frame |
|---|---|---|
| To show that adenosine enhanced DSCT will enhance regular Multidetector Spiral Computed Tomography (MSCT) "diagnostic power" to detect significant (e.g., > 50%) coronary stenosis | One day |
| Measure | Description | Time Frame |
|---|---|---|
| To assess coronary anatomical results obtained by CT Angiography (CTA) at high heart rates in terms of the rate of assessable coronary segments. | One day |
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Pilot 1:
Inclusion Criteria:
Exclusion Criteria:
Pilot 2:
All inclusions/exclusions are the same as Pilot 1, WITH THE ADDITION OF:
Inclusion Criteria:
Exclusion Criteria:
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Coronary Artery Disease
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| Name | Affiliation | Role |
|---|---|---|
| Daniel S Berman, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |