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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Radiation: Intervention group; Radiation: Control group

• Registration Number: NCT01453712
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-10
• Study Start: 2011-10
• Study First Submitted: 2011-10-14
• Study First Submitted QC: 2011-10-17
• Last Update Submitted: 2011-10-17
• Study First Posted: 2011-10-18
• Last Update Posted: 2011-10-18
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
2. signed informed consent
3. stable sinus rhythm
4. age > 18 years

Exclusion Criteria

1. known allergy to contrast agents.
2. patients with known coronary artery disease
3. pregnancy
4. no stable sinus rhythm
5. coronary ct examinations not focussing on coronary arteries

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Image quality	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 Outcome Measures

Name	Time	Method
Quantitative image quality parameters	1 month	Quantitative image quality parameters, e.g. image noise, signal and contrast intensity, signal- and contrast-to-noise-ratios
Prevalence of coronary artery plaques	1 month	Prevalence of coronary artery plaques and coronary artery plaques characteristics (non-calcified, calcified, mixed) in both study arms.
Prevalence of non-diagnostic examinations	1 month	Prevalence of non-diagnostic examinations in both study arms.
Radiation dose	1 month	Radiation dose in both study arms.
Prevalence of follow-up examinations	1 month	Prevalence of follow-up examinations in both study arms.

Trial Locations

Locations (1)

Deutsches Herzzentrum Muenchen; 🇩🇪 Muenchen, Bavaria, Germany