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
  Purpose

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


Condition Intervention
Radiation Exposure
Radiation: X-ray radiation

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reduced radiation dose Radiation: X-ray radiation
Non-inferiority image quality testing with reduced radiation dose

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Michael Söderman, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01381952     History of Changes
Other Study ID Numbers: KUH-PMS-01
Study First Received: June 20, 2011
Last Updated: September 13, 2011
Health Authority: Sweden: Regional Ethical Review Board

ClinicalTrials.gov processed this record on April 17, 2014