Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique

Coronary Artery Disease Clinical Trial

— CTDOSE  

Official title:

Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique Employed in Cardiothoracic Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272453
• Other study ID #: 2010-209
• Status: Completed
• Phase: N/A
• First received: January 6, 2011
• Last updated: May 29, 2014
• Start date: January 2011
• Est. completion date: October 2013

Study information

• Verified date: May 2014
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2640
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Aneurysm
• Coronary Artery Disease
• Coronary Disease
• Embolism
• Myocardial Ischemia
• Pulmonary Embolism

Locations

Country	Name	City	State
Saudi Arabia	King Abdul-Aziz Cardiac Center, national Guard Health Affairs	Riyadh	Kingdom of Saudi Arabia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Minneapolis Heart Institute/ Abbott Northwestern	Minneapolis	Minnesota
United States	NYU Langone Medical Center	New York	New York
United States	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan
United States	Naval Medical Center	San Diego	California
United States	William Beaumont Hospital-Troy	Troy	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Gilbert L. Raff, MD	Siemens Healthcare Diagnostics Inc

Countries where clinical trial is conducted

United States,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No