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Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique

NCT ID: NCT01272453

Last Updated: 2014-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2640 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Aortic Aneurysm Pulmonary Embolism

Keywords

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group

Data from patients in the control group will be obtained retrospectively from patient medical records and stored image data

No interventions assigned to this group

Prospective Patient Group

Data from patients in the Flash group will be obtained prospectively from scanner consoles and medical records.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens Healthcare Diagnostics Inc

INDUSTRY

Sponsor Role collaborator

Gilbert L. Raff, MD

OTHER

Sponsor Role lead

Responsible Party

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Gilbert L. Raff, MD

Medical Director, Advanced Cardiovascular Imaging

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gilbert Raff, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

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Naval Medical Center

San Diego, California, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, United States

Site Status

William Beaumont Hospital-Troy

Troy, Michigan, United States

Site Status

Minneapolis Heart Institute/ Abbott Northwestern

Minneapolis, Minnesota, United States

Site Status

NYU Langone Medical Center

New York, New York, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

King Abdul-Aziz Cardiac Center, national Guard Health Affairs

Riyadh, Kingdom of Saudi Arabia, Saudi Arabia

Site Status

Countries

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United States Saudi Arabia

Other Identifiers

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2010-209

Identifier Type: -

Identifier Source: org_study_id