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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05111496
Acronym
Optidose
Enrollment
83
Registered
2021-11-08
Start date
2020-09-24
Completion date
2023-04-12
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Total Occlusion, X-rays; Effects

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

Interventions

RADIATIONGafchromic film

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

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER
European Clinical Trial Experts Network
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Dose measured to the patient's skin at the entrance to the X-ray beam1 monthDose expressed in Gy (Peak skin dose).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026