Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-31 @ 7:19 AM
Study NCT ID:
NCT00610766
Status:
COMPLETED
Last Update Posted:
2008-03-17
First Post:
2008-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Study Overview
Official Title:
International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTECTION-I
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: