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| Name | Class |
|---|---|
| Siemens Healthcare Diagnostics Inc | INDUSTRY |
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This is a prospective, controlled observational trial of patients undergoing clinically indicated cardiothoracic computed tomography (CT), including pulmonary or aortic angiography and coronary CT angiography (CCTA).
The development of a novel CT scanner capable of sequential or fast-pitch spiral techniques in most patients (Siemens Definition Flash) represents a potentially crucial technical innovation at a particularly critical juncture. National healthcare systems are under pressure to deliver accurate and cost-effective diagnosis of an increasing number of patients and CT angiography in various settings is a proven, highly accurate technique that has been shown to improve diagnostic efficiency and reduce the cost of care.
However, there has been increasing concern about the lifetime attributable risk of cancer from radiation related to diagnostic procedures. Such concern extends to other radiation-based procedures that contribute to the cumulative lifetime radiation exposure of patients. The Flash scanner holds the promise of substantially reducing exposure resulting from a variety of examinations.
The CT DOSE multicenter trial is therefore designed to validate the extent of dose reduction attendant to the use of the Flash scanner in cardiothoracic scanning, and to determine whether image quality is preserved in spite of significant dose reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Data from patients in the control group will be obtained retrospectively from patient medical records and stored image data | ||
| Prospective Patient Group | Data from patients in the Flash group will be obtained prospectively from scanner consoles and medical records. |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiation dose | The primary endpoint is radiation dose, measured as dose-length-product (DLP, in mGy∙cm) and effective radiation dose, calculated as DLP x 0.014 (in mSv). | Time of CT scan |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Image Quality | Signal noise (standard deviation of attenuation in Hounsfield units) will be determined in regions of interest in: A) air anterior to the chest wall, B) mid-LV septum and C) mid thoracic aorta or main PA. This will be done in a sequential sample of every 5th case (approximately 600 cases total). | Time of CT Scan |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing clinically indicated cardiothoracic computed tomography (CT), including pulmonary or aortic angiography and coronary CT angiography (CCTA)at 10 sites. Patient selection will be based on a site consecutive CT scan log.
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| Name | Affiliation | Role |
|---|---|---|
| Gilbert Raff, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center | San Diego | California | 92134 | United States | ||
| Massachusetts General Hospital |
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| Boston |
| Massachusetts |
| 02114 |
| United States |
| William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | 48073 | United States |
| William Beaumont Hospital-Troy | Troy | Michigan | 48085 | United States |
| Minneapolis Heart Institute/ Abbott Northwestern | Minneapolis | Minnesota | 55407 | United States |
| NYU Langone Medical Center | New York | New York | 10006 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| King Abdul-Aziz Cardiac Center, national Guard Health Affairs | Riyadh | Kingdom of Saudi Arabia | 11426 | Saudi Arabia |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001014 | Aortic Aneurysm |
| D011655 | Pulmonary Embolism |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000783 | Aneurysm |
| D001018 | Aortic Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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