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

NCT01453712 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2011-10-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Joerg Hausleiter, MD · Deutsches Herzzentrum Muenchen

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-12-31

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01453712 on ClinicalTrials.gov