Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)
NCT ID: NCT05111496
Last Updated: 2021-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
85 participants
OBSERVATIONAL
2020-09-24
2021-11-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Gafchromic film
Before the X-ray radiation, a Gafchromic film will be placed on the patient's back at the start of the operation
Interventions
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Gafchromic film
Before the X-ray radiation, a Gafchromic film will be placed on the patient's back at the start of the operation
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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European Clinical Trial Experts Network
OTHER
Ramsay Générale de Santé
OTHER
Responsible Party
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Locations
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Hôpital privé La Louvière
Lille, Haut de France, France
Countries
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Central Contacts
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Facility Contacts
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Marie Barba
Role: primary
Jean Francois OUDET
Role: backup
Other Identifiers
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2019-A02398-49
Identifier Type: -
Identifier Source: org_study_id