RadiatiOn Dose Among Different EndOvascular Procedures: the RODEO Study

Study Overview
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Brief Summary
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Retrospective multicenter study aimed to evaluate radiation exposure associated with different interventional procedures involving interventional cardiologists, interventional radiologists and electrophysiologists.

Detailed Description
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The use fluoroscopically guided interventional procedures is progressively increasing over the past 20 years.Some previous reports have shown that the radiation dose absorbed by interventional cardiologists is the greatest registered by any medical staff exposed to X-rays. However in recent years new procedures have been introduced and validated in the setting of interventional cardiology and radiology and there is wide variation in patient dose among different procedures. Radiation issue is an important issue for patients and operators due to the acute deterministic effects and most important for the long term stochastic risk of cancer induction: however this problem is often under-evaluated. Even if the stochastic risk is an all-or-none phenomenon for any individual cell, the greater the radiation exposure, the more cells are injured. Moreover non cancerous effects are possible such as cataract formation in the eye and the probability increases with increasing dose. Radiation dose can be expressed in different ways: the Air Kerma is the amount of energy absorbed in a given mass of air, whereas the Dose Area Product (DAP) is the absorbed dose of radiation across a given surface area. Generally DAP measurements are more accurate than using Air Kerma measurements for the estimation of patient radiation dose as DAP allows for variations in field size. DAP consents a good estimation of the dose to the irradiated tissue and is an indicator for patient cancer risk. Aim of our study is to evaluate the radiation dose exposure during different fluoroscopically guided interventional procedures comparing different specialties (electrophysiology, interventional radiology, interventional cardiology). Methods From January 2013 to December 2015 all diagnostic or interventional procedures performed by interventional operators will be included in this multicenter study without exclusion criteria. Collection of data will be retrospective in a dedicated database. Radiation exposure will be assessed measuring the DAP and fluoroscopy times for each procedure. Moreover for each procedure all the centers are requested to give information about operator, patient and procedure details. End point of the study The primary end-point of the study is the comparison of DAP dose among interventional cardiologist, electrophysiologist and interventional radiologist procedures. Secondary end-point of the study is to compare fluoroscopy times among different procedures.

Official Title
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RadiatiOn Dose Among Different EndOvascular Procedures: the RODEO Study

Conditions
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Radiation Injuries

Intervention / Treatment
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* Radiation: Radiation dose expressed as DAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All procedures for which DAP values are available Exclusion Criteria: Procedures without DAP
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Interventional Cardiology<br>All procedures performed by interventional cardiologists | Radiation: Radiation dose expressed as DAP<br> <br> |
| Electrophysiology<br>All procedures performed by electrophysiologists | Radiation: Radiation dose expressed as DAP<br> <br> |
| Interventional Radiology<br>All vascular and non vascular procedures performed by interventional radiologists | Radiation: Radiation dose expressed as DAP<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dose expressed as DAP |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation dose, percutaneous coronary intervention, Coronary, Interventional radiology, Electrophysiology