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

Study Overview

• Status: Recruiting
• Conditions: Chronic Total Occlusion; X-rays; Effects
• Intervention / Treatment: Radiation: Gafchromic film

• Study Type: Observational
• Enrollment (Anticipated): 85

Contacts and Locations

Study Locations

• France
  • Haut De France
    • Lille, Haut De France, France, 59800
      • Recruiting
      • Hôpital Privé La Louvière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

Number of groups / cohorts

1

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	Dose expressed in Gy (Peak skin dose).	1 month

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Actual): October 6, 2021
• Study Completion (Anticipated): November 24, 2021

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): November 8, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

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