Image Quality and Radiation Dose in Angiography

This study has been completed.
Sponsor:
Collaborator:
Philips Medical Systems
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01381952
First received: June 20, 2011
Last updated: September 13, 2011
Last verified: June 2011

June 20, 2011
September 13, 2011
June 2011
August 2011   (final data collection date for primary outcome measure)
Image Quality [ Time Frame: Within 30 days after procedure ] [ Designated as safety issue: No ]
Simultaneous visual comparison of image quality in the two groups, by blinded reviewers. Image quality is assesed by following a specific test protocol regarding vessel visibility.
Image Quality [ Time Frame: Within 30 days after procedure ] [ Designated as safety issue: No ]
Simultaneous visual comparison of image quality in the two groups, by three blinded reviewers. Image quality is assesed by following a specific test protocol regarding vessel visibility.
Complete list of historical versions of study NCT01381952 on ClinicalTrials.gov Archive Site
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Image Quality and Radiation Dose in Angiography
Not Provided

The aim of the study is to assess image quality and diagnostic information in cerebral angiography with a lower exposure dose.

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Interventional
Not Provided
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Radiation Exposure
Radiation: X-ray radiation
Non-inferiority image quality testing with reduced radiation dose
Experimental: Reduced radiation dose
Intervention: Radiation: X-ray radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-80
  • Normal kidney function
  • Neurologically intact
  • Planned for diagnostic angiography or endovascular treatment

Exclusion Criteria:

  • Pregnancy
  • Other conditions that limit the use of contrast media or ionizing radiation
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01381952
KUH-PMS-01
No
Michael Söderman, Karolinska University Hospital
Karolinska University Hospital
Philips Medical Systems
Not Provided
Karolinska University Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP