Skip to main content
OpenTrials
Completed

NCT Number: NCT00610766

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • pregnancy
  • contraindications against contrast media

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Acronym: PROTECTION-I

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Feb 8, 2008
Registry last updated
Mar 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.