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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 20, 2011
Last Updated Date	September 13, 2011
Start Date ^ICMJE	June 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 13, 2011)	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.
Original Primary Outcome Measures ^ICMJE (submitted: June 23, 2011)	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.
Change History	Complete list of historical versions of study NCT01381952 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Image Quality and Radiation Dose in Angiography
Official Title ^ICMJE	Not Provided
Brief Summary	The aim of the study is to assess image quality and diagnostic information in cerebral angiography with a lower exposure dose.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Crossover Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Condition ^ICMJE	Radiation Exposure
Intervention ^ICMJE	Radiation: X-ray radiation Non-inferiority image quality testing with reduced radiation dose
Study Arm (s)	Experimental: Reduced radiation dose Intervention: Radiation: X-ray radiation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	September 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01381952
Other Study ID Numbers ^ICMJE	KUH-PMS-01
Has Data Monitoring Committee	No
Responsible Party	Michael Söderman, Karolinska University Hospital
Study Sponsor ^ICMJE	Karolinska University Hospital
Collaborators ^ICMJE	Philips Medical Systems
Investigators ^ICMJE	Not Provided
Information Provided By	Karolinska University Hospital
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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