CClinicalTrials.gg
Status unknownNCT01453712PROTECTION-VUpdated Oct 18, 2011

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

A Phase 4 interventional study of Control group and Intervention group in Coronary Artery Disease, sponsored by Deutsches Herzzentrum Muenchen. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2011-10-18.

Sponsored by Deutsches Herzzentrum Muenchen · Phase 4, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 95 Years
Sex
All
01

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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • coronary artery disease
  • coronary CT angiography
  • radiation dose
  • iterative image reconstruction
  • detection
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 400 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Deutsches Herzzentrum Muenchen is the lead sponsor of 112 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • No intervention
    Control group

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

    Radiation: Control group

  • Experimental
    Intervention group

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

    Radiation: Intervention group

Interventions

  • RadiationControl group

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

  • RadiationIntervention group

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month

Secondary outcomes

  1. Quantitative image quality parameters

    Quantitative image quality parameters, e.g. image noise, signal and contrast intensity, signal- and contrast-to-noise-ratios

    Time frame: 1 month

  2. Prevalence of non-diagnostic examinations

    Prevalence of non-diagnostic examinations in both study arms.

    Time frame: 1 month

  3. Prevalence of coronary artery plaques

    Prevalence of coronary artery plaques and coronary artery plaques characteristics (non-calcified, calcified, mixed) in both study arms.

    Time frame: 1 month

  4. Prevalence of follow-up examinations

    Prevalence of follow-up examinations in both study arms.

    Time frame: 1 month

  5. Radiation dose

    Radiation dose in both study arms.

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Deutsches Herzzentrum Muenchen
    Muenchen, Bavaria 80636, Germany
    • Joerg Hausleiter, MD · Contact · hausleiter@dhm.mhn.de · 49 89 1218
    • Simon Deseive, MD · Contact · deseive@dhm.mhn.de · 49 89 1218
    • Joerg Hausleiter, MD · Principal investigator
    • Simon Deseive, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26189118 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01453712
Lead sponsor
Deutsches Herzzentrum Muenchen
Responsible party
Sponsor
First posted
Oct 18, 2011
Start date
Oct 2011
Primary completion
Dec 2012 (estimated)
Last update
Oct 18, 2011

Study contacts

Joerg Hausleiter, MD
Contact
hausleiter@dhm.mhn.de
49 89 1218 ext. 1585
Simon Deseive, MD
Contact
deseive@dhm.mhn.de
49 89 1218 ext. 0
Joerg Hausleiter, MD
principal investigator · Deutsches Herzzentrum Muenchen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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