Clinical trial NCT02972736: RadiatiOn Dose Among Different EndOvascular Procedures: the RODEO Study
Official title: RadiatiOn Dose Among Different EndOvascular Procedures: the RODEO Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Injuries
Keywords: Radiation dose
percutaneous coronary intervention
Coronary
Interventional radiology
Electrophysiology
Lead sponsor: Ospedale Sandro Pertini, Roma
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 17711
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All procedures with DAP data available

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* All procedures for which DAP values are available

Exclusion Criteria:

* Procedures without DAP

Primary outcomes:
measure: Radiation dose expressed as DAP
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ospedale Sandro Pertini - ASL RM2- Rome- Italy
name: Alessandro Sciahbasi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: