Chronic Total Occlusion Clinical Trial
— OptidoseOfficial title:
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
Status | Recruiting |
Enrollment | 85 |
Est. completion date | November 24, 2021 |
Est. primary completion date | October 6, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital privé La Louvière | Lille | Haut De France |
Lead Sponsor | Collaborator |
---|---|
Ramsay Générale de Santé | European Clinical Trial Experts Network |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose measured to the patient's skin at the entrance to the X-ray beam | Dose expressed in Gy (Peak skin dose). | 1 month |
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