NCT01453712

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
RADIATION	Control group	Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).
RADIATION	Intervention group	Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-12-01
• First posted: 2011-10-18
• Last updated: 2011-10-18

Locations

1 site across 1 country: Germany