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

NCT05111496 | Unknown

• 1 other identifier: 2019-A02398-49
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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

Conditions

X-rays; Effects; Chronic Total Occlusion

Outcome Measures

Primary Outcomes (1)

• Dose measured to the patient's skin at the entrance to the X-ray beam

  Dose expressed in Gy (Peak skin dose).

  1 month

Study Arms (1)

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

Interventions

Gafchromic film RADIATION

Before the X-ray radiation, a Gafchromic film will be placed on the patient's back at the start of the operation

Patient requiring intervention (complex coronary dilation or coronary recanalization)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patient refusal to participate in the study
• Patient with known radiosensitivity factors (eg: Lupus)
• Patient having had radiotherapy treatment of the thoracic region.
• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Hôpital privé La Louvière

Lille, Haut de France, 59800, France

RECRUITING

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: September 24, 2020
• Primary Completion: October 6, 2021
• Study Completion: November 24, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-10

Locations

FR (1)