Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique

NCT01272453 | Completed

• 1 other identifier: 2010-209
• Study Type: observational
• Target: 2,640
• Locations: 2 countries
• Sites: 9

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).

Conditions

Coronary Artery Disease; Aortic Aneurysm; Pulmonary Embolism

Keywords

coronary artery disease; CT scan; coronary angiography; chest pain; aortic aneurysm; pulmonary embolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of Image Quality

  Time of CT Scan

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Gilbert L. Raff, MD: lead
• Siemens Healthcare Diagnostics Inc: collaborator

Study Sites (9)

Naval Medical Center

San Diego, California, 92134, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital-Troy

Troy, Michigan, 48085, United States

Location

Minneapolis Heart Institute/ Abbott Northwestern

Minneapolis, Minnesota, 55407, United States

Location

NYU Langone Medical Center

New York, New York, 10006, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

King Abdul-Aziz Cardiac Center, national Guard Health Affairs

Riyadh, Kingdom of Saudi Arabia, 11426, Saudi Arabia

Location

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Aneurysm; Pulmonary Embolism; Chest Pain

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilbert Raff, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, Advanced Cardiovascular Imaging

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 7, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 30, 2014

Record last verified: 2014-05

Locations

US (8); SA (1)