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Clinical Trials/NCT01453712
NCT01453712
Unknown
Phase 4

Prospective Randomized Trial On Radiation Dose Estimates Of CT Angiography In Patients Applying Iterative Image Reconstruction Techniques - The PROTECTION V Study -

Deutsches Herzzentrum Muenchen1 site in 1 country400 target enrollmentOctober 2011

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Deutsches Herzzentrum Muenchen
Enrollment
400
Locations
1
Primary Endpoint
Image quality
Last Updated
14 years ago

Overview

Brief Summary

The objective of this study is to compare a standard coronary CT angiography scan protocol with conventional image reconstruction with a scan protocol using reduced tube current and a new image reconstruction algorithm. The investigators hypothesize that the image quality of the new scan protocol is not inferior, while radiation dose estimates are reduced by around 30%.

Secondary endpoints of the study include quantitative image quality parameters, prevalence of non-diagnostic studies, prevalence of coronary artery plaques and plaque characteristics (calcified, non-calcified, mixed) and prevalence of follow-up examinations.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
December 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Deutsches Herzzentrum Muenchen
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
  • signed informed consent
  • stable sinus rhythm
  • age \> 18 years

Exclusion Criteria

  • known allergy to contrast agents.
  • patients with known coronary artery disease
  • no stable sinus rhythm
  • coronary ct examinations not focussing on coronary arteries

Outcomes

Primary Outcomes

Image quality

Time Frame: 1 month

Compared with a conventional scan protocol the use of a new scan protocol using iterative image reconstruction and reduced tube current is associated with a comparable diagnostic image quality, while the radiation dose estimates are significantly reduced.

Secondary Outcomes

  • Quantitative image quality parameters(1 month)
  • Prevalence of coronary artery plaques(1 month)
  • Prevalence of non-diagnostic examinations(1 month)
  • Radiation dose(1 month)
  • Prevalence of follow-up examinations(1 month)

Study Sites (1)

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