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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00610766

Acronym

PROTECTION-I

Enrollment

1965

Registered

2008-02-08

Start date

2007-01-31

Completion date

2008-01-31

Last updated

2008-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease

Keywords

coronary CT angiography, radiation dose estimates

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Radiation dose estimates of coronary MSCT angiography in daily practice	1 month

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results