Skip to content

Comparison of iodinated contrast media injection protocols with reduced flow rates and volumes on image quality in diagnostic cerebral angiography for the evaluation of unruptured intracranial aneurysms: towards a standardization of practices (OPIAC)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524884-18-01
Enrollment
244
Registered
2026-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-22

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

Conditions

Intracranial aneurysms

Brief summary

Ratio of exploitable 2D and 3D images, assessed by radiographers, obtained with each injection protocol (reduced flow rates/standard volumes; reduced volumes/standard flow rates; reduced flow rates and volumes), compared to the standard/empirical protocol

Detailed description

Accordance between radiographers’ assessment and interventional neuroradiologist evaluation regarding images classified as exploitable or non-exploitable, and inter- evaluator reproducibility (between radiographers, between neuroradiologists, and between radiographers and neuroradiologists);, Patient discomfort assessed orally by a radiographer or nurse in the theatre using a simple verbal scale (EVS, Échelle Verbale Simple, score 0-4) at the beginning of procedure (baseline) and after each injection/acquisition; Patient satisfaction assessed using a SAPS questionnaire, and inventory of side effects and their maximum intensity at the end of the examination, Description of the results obtained from a qualitative assessment grid and correlation with the quantitative results; Analysis of the predictive reliability of the grid in relation to images exploitability; Analysis of inter-evaluator reproducibility of the grid, Average ICM cost per protocol, depending on the number and type of vials used, and assessment of environmental impact (carbon footprint and waste management), Average examination time per protocol, including injection/acquisition time and number of repetitions required to obtain exploitable results

Interventions

DRUGVisipaque 270 550 mg/ml (<> 270 mg I/ml) solução injectável

Sponsors

Les Hopitaux Universitaires De Strasbourg
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Ratio of exploitable 2D and 3D images, assessed by radiographers, obtained with each injection protocol (reduced flow rates/standard volumes; reduced volumes/standard flow rates; reduced flow rates and volumes), compared to the standard/empirical protocol

Secondary

MeasureTime frame
Accordance between radiographers’ assessment and interventional neuroradiologist evaluation regarding images classified as exploitable or non-exploitable, and inter- evaluator reproducibility (between radiographers, between neuroradiologists, and between radiographers and neuroradiologists);, Patient discomfort assessed orally by a radiographer or nurse in the theatre using a simple verbal scale (EVS, Échelle Verbale Simple, score 0-4) at the beginning of procedure (baseline) and after each injection/acquisition; Patient satisfaction assessed using a SAPS questionnaire, and inventory of side effects and their maximum intensity at the end of the examination, Description of the results obtained from a qualitative assessment grid and correlation with the quantitative results; Analysis of the predictive reliability of the grid in relation to images exploitability; Analysis of inter-evaluator reproducibility of the grid, Average ICM cost per protocol, depending on the number and type of via

Outcome results

None listed

Source: EU CTIS · Data processed: May 23, 2026