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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01453712
First Posted: October 18, 2011
Last Update Posted: October 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease Radiation: Control group Radiation: Intervention group Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Prospective Randomized Trial On Radiation Dose Estimates Of CT Angiography In Patients Applying Iterative Image Reconstruction Techniques - The PROTECTION V Study -

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

  • Prevalence of non-diagnostic examinations [ Time Frame: 1 month ]
    Prevalence of non-diagnostic examinations in both study arms.

  • 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.

  • Prevalence of follow-up examinations [ Time Frame: 1 month ]
    Prevalence of follow-up examinations in both study arms.

  • Radiation dose [ Time Frame: 1 month ]
    Radiation dose in both study arms.


Estimated Enrollment: 400
Study Start Date: October 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453712


Contacts
Contact: Joerg Hausleiter, MD 49 89 1218 ext 1585 hausleiter@dhm.mhn.de
Contact: Simon Deseive, MD 49 89 1218 ext 0 deseive@dhm.mhn.de

Locations
Germany
Deutsches Herzzentrum Muenchen Recruiting
Muenchen, Bavaria, Germany, 80636
Contact: Joerg Hausleiter, MD    49 89 1218 ext 1585    hausleiter@dhm.mhn.de   
Contact: Simon Deseive, MD    49 89 1218    deseive@dhm.mhn.de   
Principal Investigator: Joerg Hausleiter, MD         
Sub-Investigator: Simon Deseive, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Principal Investigator: Joerg Hausleiter, MD Deutsches Herzzentrum Muenchen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01453712     History of Changes
Other Study ID Numbers: GE-DHM-PROTV
First Submitted: October 14, 2011
First Posted: October 18, 2011
Last Update Posted: October 18, 2011
Last Verified: October 2011

Keywords provided by Deutsches Herzzentrum Muenchen:
coronary artery disease
coronary CT angiography
radiation dose
iterative image reconstruction
detection

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases