RadiatiOn Dose Among Different EndOvascular Procedures: the RODEO Study (RODEO)

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

Study Overview

• Status: Completed
• Conditions: Radiation Injuries
• Intervention / Treatment: Radiation: Radiation dose expressed as DAP

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.

• Study Type: Observational
• Enrollment (Actual): 17711

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All procedures with DAP data available

Description

Inclusion Criteria:

• All procedures for which DAP values are available

Exclusion Criteria:

• Procedures without DAP

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Interventional Cardiology; All procedures performed by interventional cardiologists	Radiation: Radiation dose expressed as DAP
Electrophysiology; All procedures performed by electrophysiologists	Radiation: Radiation dose expressed as DAP
Interventional Radiology; All vascular and non vascular procedures performed by interventional radiologists	Radiation: Radiation dose expressed as DAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radiation dose expressed as DAP	24 hours

Collaborators and Investigators

• Sponsor: Ospedale Sandro Pertini, Roma
• Investigators: Principal Investigator: Alessandro Sciahbasi, MD, PhD, Ospedale Sandro Pertini - ASL RM2- Rome- Italy

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimated): November 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; Coronary; Electrophysiology; Interventional radiology; Radiation dose
• Additional Relevant MeSH Terms: Wounds and Injuries; Radiation Injuries
• Other Study ID Numbers: Pertini04