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

German Heart Center Munich

Status: Completed

Conditions: Coronary Disease

Study type: Observational

Funder types: Other

Identifiers

NCT00610766

GE IDE No. R00107

Details and patient eligibility

About

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

Full 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

Enrollment: 1,965 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

1,965 participants in 1 patient group

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