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

Chronic Total Occlusion Clinical Trial

— Optidose  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05111496
• Other study ID #: 2019-A02398-49
• Status: Recruiting
• Start date: September 24, 2020
• Est. completion date: November 24, 2021

Study information

• Verified date: October 2021
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Chronic Total Occlusion
• X-rays; Effects

Intervention

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

Locations

Country	Name	City	State
France	Hôpital privé La Louvière	Lille	Haut De France

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

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