NCT01111760

Brief Summary

The purpose of this study is to compare the radiation exposure of a variety of chest CT examinations performed on the current state of the art CT scanners (64 slice, dual source CT scanner) with the radiation exposure for identical chest CT examinations performed on the Siemens Flash CT scanner (high pitch dual source spiral technique).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

2.6 years

First QC Date

April 26, 2010

Last Update Submit

April 3, 2013

Conditions

Keywords

cardiovascular diseaseheart CT scanCT scanpulmonary embolismsaortography

Outcome Measures

Primary Outcomes (1)

  • Comparison of the radiation dose for chest CT examinations using current technology with radiation dose exposure using the newest generation CT scanner.

    The primary objective of this study is to compare the estimated radiation dose for chest CT examinations (cardiac and non cardiac) performed using current technology (ie. Retrospective gated CT examinations on the 64 slice and dual source Definition Siemens CT scanners) with the radiation exposure using the newest generation CT scanner (high pitch dual source spiral technique).

    Time of CT scan

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

any patient receiving a coronary CT scan and a chest CT for pulmonary embolisms, pulmonary nodules, aortic pathologies

You may qualify if:

  • All patients who undergo chest CT examinations (including cardiac CTA, and non cardiac CT examinations including pulmonary embolism, lung nodule and aortic pathology protocols)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCardiovascular DiseasesPulmonary EmbolismAortic Aneurysm

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisAneurysmAortic Diseases

Study Officials

  • Michael Gallagher, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR
  • Gilbert Raff, MD

    Corewell Health East

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 28, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations