Coronary Artery Disease
Conditions
Interventions
Group 1: Arm A: Without AI, with standard dose
Group 2: Arm B: With AI and standard dose
Group 3: Arm C: With AI and lower dose
Sponsors
Universitätsklinikum Gießen und Marburg - Standort Gießen, Klinisches Studienzentrum für Kardiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age = 18 years • Written informed consent
Exclusion criteria
Exclusion criteria: • Lack of written informed consent • Pregnancy or breastfeeding • Age < 18 years • Significant language barrier • Current participation in another cardiology intervention study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of whether AI-assisted OPTIQ dose control achieves a significant relative dose reduction per procedure while maintaining image quality. The following parameters will be used for this purpose: • Dose area product per procedure • Cumulative initial dose (Air Kerma, Karef) • Fluoroscopy time • Image quality (quantitative) • Image quality (qualitative) • Image usage/use of additional images | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality and safety endpoints, subgroup analyses. • Contrast agent consumption and total image sequences used • Total procedure time • Rate of non-diagnostic images/cine runs, re-exposures, or repeat scans • Inter-observer reliability of image quality • Safety endpoints • Subgroup analyses • Feasibility of AI integration | — |
Countries
Germany
Contacts
Public ContactBernhard Unsöld
Universitätsklinikum Gießen und Marburg - Standort Gießen
Outcome results
None listed