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International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice (PROTECTION-I)

This study has been completed.

Sponsored by: Deutsches Herzzentrum Muenchen
Information provided by: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00610766
  Purpose

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


Condition
Coronary Disease

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Radiation dose estimates of coronary MSCT angiography in daily practice [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of dose estimates between 16-slice, 64-slice, DSCT and other CT systems [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Frequency of dose-saving algorithm's use (e.g.: ECG-dose pulsing / Care Dose 4D / 100kv [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment:   1965
Study Start Date:   January 2007
Study Completion Date:   January 2008
Primary Completion Date:   December 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts
1

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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

patients with indication for cardiac imaging by MSCT


Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610766

Locations
Germany
Deutsches Herzzentrum Muenchen    
      Munich, Germany, 80636

Sponsors and Collaborators
Deutsches Herzzentrum Muenchen

Investigators
Principal Investigator:     Joerg Hausleiter, MD     Deutsches Herzzentrum Muenchen    
  More Information


Responsible Party:   Deutsches Herzzentrum ( PD Dr. Joerg Hausleiter )
Study ID Numbers:   GE IDE No. R00107
First Received:   January 28, 2008
Last Updated:   March 14, 2008
ClinicalTrials.gov Identifier:   NCT00610766
Health Authority:   Germany: Ethics Commission

Keywords provided by Deutsches Herzzentrum Muenchen:
coronary CT angiography  
radiation dose estimates  

Study placed in the following topic categories:
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 15, 2008




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