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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01453712

Acronym

PROTECTION-V

Enrollment

400

Registered

2011-10-18

Start date

2011-10-31

Completion date

Unknown

Last updated

2011-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

coronary artery disease, coronary CT angiography, radiation dose, iterative image reconstruction, detection

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.

Interventions

RADIATIONControl group

Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).

RADIATIONIntervention group

Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 non-diagnostic examinations	1 month	Prevalence of non-diagnostic examinations in both study arms.
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 follow-up examinations	1 month	Prevalence of follow-up examinations in both study arms.
Radiation dose	1 month	Radiation dose in both study arms.

Countries

Germany

Contacts

Primary ContactJoerg Hausleiter, MD

hausleiter@dhm.mhn.de49 89 1218

Backup ContactSimon Deseive, MD

deseive@dhm.mhn.de49 89 1218

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026