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CompletedNCT00610766PROTECTION-IUpdated Mar 17, 2008

International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice

An observational study in Coronary Disease, sponsored by Deutsches Herzzentrum Muenchen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-03-17.

Sponsored by Deutsches Herzzentrum Muenchen · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,965
Ages
18 Years and older
Sex
All
01

Study summary

Estimation of radiation dose of coronary multislice computed tomography (MSCT) angiography in daily practice in an international, multicenter and vendor-independent trial.

Read the detailed description

Prospective analysis of cardiac CT angiographies enrolled over 1 month

Collection of 1 axial data set and the "patient dose protocol" (including kV, mAs, CTDI, DLP, etc.) on a CD

Dose estimation in dose/cm with the use of a method proposed by the European Working Group for Guidelines on Quality Criteria in CT.

Assessment of diagnostic, qualitative image quality on a per-vessel basis by the participating study sites and in randomly selected cases by the primary study investigators (approximately 5-10% of patients to "spot check" interobserver variability of image quality assessments)

Assessment of image quality with the use of quantitative parameters including image noise, signal-to-noise and contrast-to-noise ratios

02

Conditions studied

  • Coronary Disease

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Keywords

  • coronary CT angiography
  • radiation dose estimates
03

In context

Coronary Disease

2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.

This study's enrollment of 1,965 is above the median of 460 across 953 observational studies indexed under Coronary Disease.

Browse Coronary 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 and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with indication for cardiac imaging by MSCT

Inclusion criteria

  • assessment of coronary arteries
  • acute chest pain or "triple rule out"
  • evaluation after PCI (stents)
  • evaluation of bypass grafts
  • before or after EP study
  • cardiac anomalies

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • contraindications against contrast media
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,965 participants (actual)

Groups and cohorts

  • 1
06

What researchers measure

Primary outcomes

  1. Radiation dose estimates of coronary MSCT angiography in daily practice

    Time frame: 1 month

Secondary outcomes

  1. Comparison of dose estimates between 16-slice, 64-slice, DSCT and other CT systems

    Time frame: 1 month

  2. Frequency of dose-saving algorithm's use (e.g.: ECG-dose pulsing / Care Dose 4D / 100kv

    Time frame: 1 month

  3. Assessment of potentials for additional dose savings (e.g. entire scan length; the distance between scan start to begin of coronary arteries and distance end of coronary arteries to end of scan)

    Time frame: 1 month

07

Study locations

1 site
  • Deutsches Herzzentrum Muenchen
    Munich, 80636, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00610766
Lead sponsor
Deutsches Herzzentrum Muenchen
First posted
Feb 8, 2008
Start date
Jan 2007
Primary completion
Dec 2007
Completion
Jan 2008
Last update
Mar 17, 2008

Study contacts

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 completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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