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

• Conditions: X-rays; Effects; Chronic Total Occlusion
• Interventions: Radiation: Gafchromic film

• Registration Number: NCT05111496
• Lead Sponsor: Ramsay Générale de Santé

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-24
• Status Verified: 2021-10
• Primary Completion: 2021-10-06
• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08
• Study Completion: 2021-11-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient requiring intervention (complex coronary dilation or coronary recanalization)	Gafchromic film	Patient requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma\> 3Gy): complex coronary dilation, coronary recanalization

Primary Outcome Measures

Name	Time	Method
Dose measured to the patient's skin at the entrance to the X-ray beam	1 month	Dose expressed in Gy (Peak skin dose).

Trial Locations

Locations (1)

Hôpital privé La Louvière; 🇫🇷 Lille, Haut De France, France