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

Ramsay Générale de Santé

Status: Unknown

Conditions: Chronic Total Occlusion; X-rays; Effects

Treatments: Radiation: Gafchromic film

Study type: Observational

Funder types: Other

Identifiers

NCT05111496

2019-A02398-49

Details and patient eligibility

About

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

Enrollment: 85 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

85 participants in 1 patient group

Patient requiring intervention (complex coronary dilation or coronary recanalization)

Description:

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

Treatment:

Radiation: Gafchromic film