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 because the information has not been verified recently.
Verified October 2011 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01453712
First received: October 14, 2011
Last updated: October 17, 2011
Last verified: October 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Prevalence of non-diagnostic examinations in both study arms.

  • Prevalence of coronary artery plaques [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Prevalence of follow-up examinations in both study arms.

  • Radiation dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01453712     History of Changes
Other Study ID Numbers: GE-DHM-PROTV
Study First Received: October 14, 2011
Last Updated: October 17, 2011
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 26, 2014