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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

X-rays; Effects Chronic Total Occlusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital privé La Louvière

Lille, Haut de France, 59800, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gafchromic film

Radiation

Before the X-ray radiation, a Gafchromic film will be placed on the patient's back at the start of the operation

Primary outcomes

Dose measured to the patient's skin at the entrance to the X-ray beam

Time frame: 1 month

Dose expressed in Gy (Peak skin dose).

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

European Clinical Trial Experts Network

Registry information

Acronym: Optidose

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Nov 8, 2021
Registry last updated: Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed