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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Control group
Intervention group
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring coronary artery disease, coronary CT angiography, radiation dose, iterative image reconstruction, detection

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Deutsches Herzzentrum MuenchenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2011
Last Updated
October 17, 2011
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT01453712
Brief Title
Prospective Randomized Trial On Radiation Dose Estimates Of CT Angiography In Patients Applying Iterative Image Reconstruction Techniques - The PROTECTION V Study -
Acronym
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 -
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, coronary CT angiography, radiation dose, iterative image reconstruction, detection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.
Intervention Type
Radiation
Intervention Name(s)
Control group
Intervention Description
Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).
Intervention Type
Radiation
Intervention Name(s)
Intervention group
Intervention Description
Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.
Primary Outcome Measure Information:
Title
Image quality
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Quantitative image quality parameters
Description
Quantitative image quality parameters, e.g. image noise, signal and contrast intensity, signal- and contrast-to-noise-ratios
Time Frame
1 month
Title
Prevalence of non-diagnostic examinations
Description
Prevalence of non-diagnostic examinations in both study arms.
Time Frame
1 month
Title
Prevalence of coronary artery plaques
Description
Prevalence of coronary artery plaques and coronary artery plaques characteristics (non-calcified, calcified, mixed) in both study arms.
Time Frame
1 month
Title
Prevalence of follow-up examinations
Description
Prevalence of follow-up examinations in both study arms.
Time Frame
1 month
Title
Radiation dose
Description
Radiation dose in both study arms.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries) signed informed consent stable sinus rhythm age > 18 years Exclusion Criteria: known allergy to contrast agents. patients with known coronary artery disease pregnancy no stable sinus rhythm coronary ct examinations not focussing on coronary arteries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joerg Hausleiter, MD
Phone
49 89 1218
Ext
1585
Email
hausleiter@dhm.mhn.de
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Deseive, MD
Phone
49 89 1218
Ext
0
Email
deseive@dhm.mhn.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joerg Hausleiter, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum Muenchen
City
Muenchen
State/Province
Bavaria
ZIP/Postal Code
80636
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joerg Hausleiter, MD
Phone
49 89 1218
Ext
1585
Email
hausleiter@dhm.mhn.de
First Name & Middle Initial & Last Name & Degree
Simon Deseive, MD
Phone
49 89 1218
Email
deseive@dhm.mhn.de
First Name & Middle Initial & Last Name & Degree
Joerg Hausleiter, MD
First Name & Middle Initial & Last Name & Degree
Simon Deseive, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26189118
Citation
Deseive S, Chen MY, Korosoglou G, Leipsic J, Martuscelli E, Carrascosa P, Mirsadraee S, White C, Hadamitzky M, Martinoff S, Menges AL, Bischoff B, Massberg S, Hausleiter J. Prospective Randomized Trial on Radiation Dose Estimates of CT Angiography Applying Iterative Image Reconstruction: The PROTECTION V Study. JACC Cardiovasc Imaging. 2015 Aug;8(8):888-96. doi: 10.1016/j.jcmg.2015.02.024. Epub 2015 Jul 15.
Results Reference
derived

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

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