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

July 15, 2026 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Haut de France
      • Lille, Haut de France, France, 59800
        • Hôpital Privé La Louvière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient over 18 years-old, requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma> 3Gy): complex coronary dilation, coronary recanalization

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient requiring intervention (complex coronary dilation or coronary recanalization)
Patient requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma> 3Gy): complex coronary dilation, coronary recanalization
Radiation: Gafchromic film
Before the X-ray radiation, a Gafchromic film will be placed on the patient's back at the start of the operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Collaborators

European Clinical Trial Experts Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Actual)

December 16, 2022

Study Completion (Actual)

April 12, 2023

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-A02398-49

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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