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

October 17, 2011 updated by: Deutsches Herzzentrum Muenchen

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Muenchen, Bavaria, Germany, 80636
        • Recruiting
        • Deutsches Herzzentrum Muenchen
        • Principal Investigator:
          • Joerg Hausleiter, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Simon Deseive, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).
Radiation: Control group
Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).
Experimental: Intervention group
Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.
Radiation: Intervention group
Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image quality
Time Frame: 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.
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Investigators

  • Principal Investigator: Joerg Hausleiter, MD, Deutsches Herzzentrum Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

October 14, 2011

First Submitted That Met QC Criteria

October 17, 2011

First Posted (Estimate)

October 18, 2011

Study Record Updates

Last Update Posted (Estimate)

October 18, 2011

Last Update Submitted That Met QC Criteria

October 17, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE-DHM-PROTV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe