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

Coronary Disease Clinical Trial

— PROTECTION-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610766
• Other study ID #: GE IDE No. R00107
• Status: Completed
• Phase: N/A
• First received: January 28, 2008
• Last updated: March 14, 2008
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: March 2008
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1965
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation dose estimates of coronary MSCT angiography in daily practice		1 month	No
Secondary	Comparison of dose estimates between 16-slice, 64-slice, DSCT and other CT systems		1 month	No
Secondary	Frequency of dose-saving algorithm's use (e.g.: ECG-dose pulsing / Care Dose 4D / 100kv		1 month	No
Secondary	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	No