Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique (CTDOSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01272453
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : May 30, 2014
Siemens Healthcare Diagnostics Inc
Information provided by (Responsible Party):
Gilbert L. Raff, MD, William Beaumont Hospitals

Brief Summary:
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).

Condition or disease
Coronary Artery Disease Aortic Aneurysm Pulmonary Embolism

Detailed Description:

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
Actual Enrollment : 2640 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique Employed in Cardiothoracic Imaging
Study Start Date : January 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

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.

Primary Outcome Measures :
  1. Radiation dose [ Time Frame: Time of CT scan ]
    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).

Secondary Outcome Measures :
  1. Assessment of Image Quality [ Time Frame: Time of CT Scan ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

Inclusion Criteria:

  • Scans from patients undergoing clinically indicated pulmonary angiography, aortography and/or CCTA.
  • Age greater than or equal to 18 years.

Exclusion Criteria:

  • No exclusions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01272453

United States, California
Naval Medical Center
San Diego, California, United States, 92134
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital-Troy
Troy, Michigan, United States, 48085
United States, Minnesota
Minneapolis Heart Institute/ Abbott Northwestern
Minneapolis, Minnesota, United States, 55407
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10006
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Saudi Arabia
King Abdul-Aziz Cardiac Center, national Guard Health Affairs
Riyadh, Kingdom of Saudi Arabia, Saudi Arabia, 11426
Sponsors and Collaborators
Gilbert L. Raff, MD
Siemens Healthcare Diagnostics Inc
Principal Investigator: Gilbert Raff, MD William Beaumont Hospitals

Responsible Party: Gilbert L. Raff, MD, Medical Director, Advanced Cardiovascular Imaging, William Beaumont Hospitals Identifier: NCT01272453     History of Changes
Other Study ID Numbers: 2010-209
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014

Keywords provided by Gilbert L. Raff, MD, William Beaumont Hospitals:
coronary artery disease
CT scan
coronary angiography
chest pain
aortic aneurysm
pulmonary embolism

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Aortic Aneurysm
Pulmonary Embolism
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis
Aortic Diseases
Lung Diseases
Respiratory Tract Diseases