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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.
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00610766
First received: January 28, 2008
Last updated: March 14, 2008
Last verified: March 2008
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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)

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

No publications provided

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

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

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 16, 2013