RadiatiOn Dose Among Different EndOvascular Procedures: the RODEO Study

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Radiation Injuries

Clinical Trial Details

NCT number	NCT02972736
Study type	Observational
Source	Ospedale Sandro Pertini, Roma
Contact
Status	Completed
Phase	N/A
Start date	January 2016
Completion date	December 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

RadiatiOn Dose Among Different EndOvascular Procedures: the RODEO Study — RODEO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms