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.
Study Type
OBSERVATIONAL
Enrollment
2,640
Naval Medical Center
San Diego, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States
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 frame: Time of CT scan
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 frame: Time of CT Scan
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William Beaumont Hospital-Troy
Troy, Michigan, United States
Minneapolis Heart Institute/ Abbott Northwestern
Minneapolis, Minnesota, United States
NYU Langone Medical Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
King Abdul-Aziz Cardiac Center, national Guard Health Affairs
Riyadh, Kingdom of Saudi Arabia, Saudi Arabia