Image Quality and Radiation Dose in Angiography
This study has been completed.
Sponsor:
Karolinska University Hospital
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
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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 May 23, 2013