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

German Heart Center Munich

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Radiation: Intervention group; Radiation: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT01453712

GE-DHM-PROTV

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

Control group

No Intervention group

Description:

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

Treatment:

Radiation: Control group

Intervention group

Experimental group

Description:

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

Treatment:

Radiation: Intervention group