Clinical trial NCT01272453: Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique
Official title: Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique Employed in Cardiothoracic Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Aortic Aneurysm
Pulmonary Embolism
Keywords: coronary artery disease
CT scan
coronary angiography
chest pain
aortic aneurysm
pulmonary embolism
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Siemens Healthcare Diagnostics Inc
First posted: 2011-01-07
Enrollment: 2640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiation dose
timeFrame: Time of CT scan
Secondary outcomes:
measure: Assessment of Image Quality
timeFrame: Time of CT Scan
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital-Royal Oak
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital-Troy
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute/ Abbott Northwestern
state: Minnesota
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Riyadh
country: Saudi Arabia
facility: King Abdul-Aziz Cardiac Center, national Guard Health Affairs
state: Kingdom of Saudi Arabia
Study officials:
affiliation: William Beaumont Hospitals
name: Gilbert Raff, MD
role: PRINCIPAL_INVESTIGATOR
References: