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

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

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Pulmonary Embolism; Aortic Aneurysm

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
• Enrollment (Actual): 2640

Contacts and Locations

Study Locations

• Saudi Arabia
  • Kingdom of Saudi Arabia
    • Riyadh, Kingdom of Saudi Arabia, Saudi Arabia, 11426
      • King Abdul-Aziz Cardiac Center, national Guard Health Affairs
• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital-Royal Oak
    • Troy, Michigan, United States, 48085
      • William Beaumont Hospital-Troy
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute/ Abbott Northwestern
  • New York
    • New York, New York, United States, 10006
      • NYU Langone Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Gilbert L. Raff, MD
• Collaborators: Siemens Healthcare Diagnostics Inc
• Investigators: Principal Investigator: Gilbert Raff, MD, William Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: January 6, 2011
• First Submitted That Met QC Criteria: January 6, 2011
• First Posted (Estimate): January 7, 2011

Study Record Updates

• Last Update Posted (Estimate): May 30, 2014
• Last Update Submitted That Met QC Criteria: May 29, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: chest pain; coronary artery disease; aortic aneurysm; pulmonary embolism; coronary angiography; CT scan
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lung Diseases; Embolism and Thrombosis; Aortic Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Embolism; Aneurysm; Pulmonary Embolism; Aortic Aneurysm
• Other Study ID Numbers: 2010-209