Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)

Ramsay Générale de Santé1 site in 1 country85 target enrollmentSeptember 24, 2020

ConditionsX-rays; Effects Chronic Total Occlusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: X-rays; Effects
Sponsor: Ramsay Générale de Santé
Enrollment: 85
Locations: 1
Primary Endpoint: Dose measured to the patient's skin at the entrance to the X-ray beam
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is therefore to study the actual doses of X-rays delivered to the patient's skin during recanalization of a coronary artery in a context of Chronic Total Occlusion

Registry

clinicaltrials.gov

Start Date

September 24, 2020

End Date

November 24, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ramsay Générale de Santé

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient over 18 years-old
•Patient requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma\> 3Gy): complex coronary dilation, coronary recanalization
•Patient benefiting from a social protection insurance
•Patient having been informed and not objecting to this research

Exclusion Criteria

•Patient refusal to participate in the study
•Patient with known radiosensitivity factors (eg: Lupus)
•Patient having had radiotherapy treatment of the thoracic region.
•Patient whose sum of radiation doses to the skin\> 0.5 Gy in the thoracic region in the 3 months preceding inclusion.
•Patient participating in another clinical study
•Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
•Pregnant or breastfeeding woman
•Patient hospitalized without consent.