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

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ClinicalTrials.gov Identifier: NCT00610766
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : March 17, 2008
Sponsor:
Information provided by:

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

Condition or disease
Coronary Disease

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


Study Design

Study Type : Observational
Actual Enrollment : 1965 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice
Study Start Date : January 2007
Primary Completion Date : December 2007
Study Completion Date : January 2008
Groups and Cohorts

Group/Cohort
1


Outcome Measures

Primary Outcome Measures :
  1. Radiation dose estimates of coronary MSCT angiography in daily practice [ Time Frame: 1 month ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: PD Dr. Joerg Hausleiter, Deutsches Herzzentrum
ClinicalTrials.gov Identifier: NCT00610766     History of Changes
Other Study ID Numbers: GE IDE No. R00107
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: March 17, 2008
Last Verified: March 2008

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