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

Completed

• Conditions: Coronary Disease

• Registration Number: NCT00610766
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

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

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 Timeline

• Study Start: 2007-01
• Primary Completion: 2007-12
• Study Completion: 2008-01
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-02-08
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-14
• Last Update Posted: 2008-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1965

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiation dose estimates of coronary MSCT angiography in daily practice	1 month

Secondary Outcome Measures

Name	Time	Method
Comparison of dose estimates between 16-slice, 64-slice, DSCT and other CT systems	1 month
Frequency of dose-saving algorithm's use (e.g.: ECG-dose pulsing / Care Dose 4D / 100kv	1 month
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)	1 month

Trial Locations

Locations (1)

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany