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

Coronary Artery Disease Clinical Trial

— PROTECTION-V  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01453712
• Other study ID #: GE-DHM-PROTV
• Status: Recruiting
• Phase: Phase 4
• First received: October 14, 2011
• Last updated: October 17, 2011
• Start date: October 2011

Study information

• Verified date: October 2011
• Source: Deutsches Herzzentrum Muenchen
• Contact: Joerg Hausleiter, MD
• Phone: 49 89 1218
• Email: hausleiter[@]dhm.mhn.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Muenchen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image quality	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.	1 month	No
Secondary	Quantitative image quality parameters	Quantitative image quality parameters, e.g. image noise, signal and contrast intensity, signal- and contrast-to-noise-ratios	1 month	No
Secondary	Prevalence of non-diagnostic examinations	Prevalence of non-diagnostic examinations in both study arms.	1 month	No
Secondary	Prevalence of coronary artery plaques	Prevalence of coronary artery plaques and coronary artery plaques characteristics (non-calcified, calcified, mixed) in both study arms.	1 month	No
Secondary	Prevalence of follow-up examinations	Prevalence of follow-up examinations in both study arms.	1 month	No
Secondary	Radiation dose	Radiation dose in both study arms.	1 month	No