<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02972736</url>
  </required_header>
  <id_info>
    <org_study_id>Pertini04</org_study_id>
    <nct_id>NCT02972736</nct_id>
  </id_info>
  <brief_title>RadiatiOn Dose Among Different EndOvascular Procedures: the RODEO Study</brief_title>
  <acronym>RODEO</acronym>
  <official_title>RadiatiOn Dose Among Different EndOvascular Procedures: the RODEO Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale Sandro Pertini, Roma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ospedale Sandro Pertini, Roma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Retrospective multicenter study aimed to evaluate radiation exposure associated with&#xD;
      different interventional procedures involving interventional cardiologists, interventional&#xD;
      radiologists and electrophysiologists.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use fluoroscopically guided interventional procedures is progressively increasing over&#xD;
      the past 20 years.Some previous reports have shown that the radiation dose absorbed by&#xD;
      interventional cardiologists is the greatest registered by any medical staff exposed to&#xD;
      X-rays. However in recent years new procedures have been introduced and validated in the&#xD;
      setting of interventional cardiology and radiology and there is wide variation in patient&#xD;
      dose among different procedures.&#xD;
&#xD;
      Radiation issue is an important issue for patients and operators due to the acute&#xD;
      deterministic effects and most important for the long term stochastic risk of cancer&#xD;
      induction: however this problem is often under-evaluated. Even if the stochastic risk is an&#xD;
      all-or-none phenomenon for any individual cell, the greater the radiation exposure, the more&#xD;
      cells are injured. Moreover non cancerous effects are possible such as cataract formation in&#xD;
      the eye and the probability increases with increasing dose.&#xD;
&#xD;
      Radiation dose can be expressed in different ways: the Air Kerma is the amount of energy&#xD;
      absorbed in a given mass of air, whereas the Dose Area Product (DAP) is the absorbed dose of&#xD;
      radiation across a given surface area. Generally DAP measurements are more accurate than&#xD;
      using Air Kerma measurements for the estimation of patient radiation dose as DAP allows for&#xD;
      variations in field size. DAP consents a good estimation of the dose to the irradiated tissue&#xD;
      and is an indicator for patient cancer risk.&#xD;
&#xD;
      Aim of our study is to evaluate the radiation dose exposure during different fluoroscopically&#xD;
      guided interventional procedures comparing different specialties (electrophysiology,&#xD;
      interventional radiology, interventional cardiology).&#xD;
&#xD;
      Methods From January 2013 to December 2015 all diagnostic or interventional procedures&#xD;
      performed by interventional operators will be included in this multicenter study without&#xD;
      exclusion criteria.&#xD;
&#xD;
      Collection of data will be retrospective in a dedicated database. Radiation exposure will be&#xD;
      assessed measuring the DAP and fluoroscopy times for each procedure. Moreover for each&#xD;
      procedure all the centers are requested to give information about operator, patient and&#xD;
      procedure details.&#xD;
&#xD;
      End point of the study The primary end-point of the study is the comparison of DAP dose among&#xD;
      interventional cardiologist, electrophysiologist and interventional radiologist procedures.&#xD;
&#xD;
      Secondary end-point of the study is to compare fluoroscopy times among different procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Radiation dose expressed as DAP</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">17711</enrollment>
  <condition>Radiation Injuries</condition>
  <arm_group>
    <arm_group_label>Interventional Cardiology</arm_group_label>
    <description>All procedures performed by interventional cardiologists</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electrophysiology</arm_group_label>
    <description>All procedures performed by electrophysiologists</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interventional Radiology</arm_group_label>
    <description>All vascular and non vascular procedures performed by interventional radiologists</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation dose expressed as DAP</intervention_name>
    <arm_group_label>Electrophysiology</arm_group_label>
    <arm_group_label>Interventional Cardiology</arm_group_label>
    <arm_group_label>Interventional Radiology</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All procedures with DAP data available&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All procedures for which DAP values are available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Procedures without DAP&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alessandro Sciahbasi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ospedale Sandro Pertini - ASL RM2- Rome- Italy</affiliation>
  </overall_official>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>April 4, 2017</last_update_submitted>
  <last_update_submitted_qc>April 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ospedale Sandro Pertini, Roma</investigator_affiliation>
    <investigator_full_name>Alessandro Sciahbasi, MD</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Radiation dose</keyword>
  <keyword>percutaneous coronary intervention</keyword>
  <keyword>Coronary</keyword>
  <keyword>Interventional radiology</keyword>
  <keyword>Electrophysiology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Radiation Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02972736
org study id: Pertini04
nct id: NCT02972736
lead sponsor: 
has dmc: No
Retrospective multicenter study aimed to evaluate radiation exposure associated with
      different interventional procedures involving interventional cardiologists, interventional
      radiologists and electrophysiologists.
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.
observational model: Cohort
time perspective: Retrospective
measure: Radiation dose expressed as DAP
time frame: 24 hours
arm group label: Interventional Cardiology
description: All procedures performed by interventional cardiologists
arm group label: Electrophysiology
description: All procedures performed by electrophysiologists
arm group label: Interventional Radiology
description: All vascular and non vascular procedures performed by interventional radiologists
intervention type: Radiation
intervention name: Radiation dose expressed as DAP
arm group label: Electrophysiology
arm group label: Interventional Cardiology
arm group label: Interventional Radiology
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Alessandro Sciahbasi, MD, PhD
role: Principal Investigator
affiliation: Ospedale Sandro Pertini - ASL RM2- Rome- Italy
responsible party type: Principal Investigator
investigator affiliation: Ospedale Sandro Pertini, Roma
investigator full name: Alessandro Sciahbasi, MD
investigator title: MD, PhD
mesh term: Radiation Injuries