Radiation InjuriesRODEONCT02972736
RadiatiOn Dose Among Different EndOvascular Procedures: the RODEO Study
An observational study of Radiation Injuries, run by Ospedale Sandro Pertini, Roma.
Trial summary
Retrospective multicenter study aimed to evaluate radiation exposure associated with different interventional procedures involving interventional cardiologists, interventional radiologists and electrophysiologists. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiation Injuries
- What is being tested?
- Radiation dose expressed as DAP
- Type of treatment
- Surgery or procedure
- How many people
- 17,711 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All procedures with DAP data available
Who may be able to join
- All procedures for which DAP values are available
Who cannot join
- Procedures without DAP
About this study
Retrospective multicenter study aimed to evaluate radiation exposure associated with different interventional procedures involving interventional cardiologists, interventional radiologists and electrophysiologists.
Read the 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.
- Conditions
- Radiation Injuries
- Being tested
- Radiation dose expressed as DAP
- Keywords
- Radiation dose, percutaneous coronary intervention, Coronary, Interventional radiology, Electrophysiology
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation dose expressed as DAPRadiation
| Study group | Role | What they receive |
|---|---|---|
| Interventional Cardiology | All procedures performed by interventional cardiologists Receives: Radiation: Radiation dose expressed as DAP | |
| Electrophysiology | All procedures performed by electrophysiologists Receives: Radiation: Radiation dose expressed as DAP | |
| Interventional Radiology | All vascular and non vascular procedures performed by interventional radiologists Receives: Radiation: Radiation dose expressed as DAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose expressed as DAP
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 17,711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Sandro Pertini, Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Sciahbasi, MD, Ospedale Sandro Pertini, Roma
- Investigators
- Alessandro Sciahbasi, MD, PhD, Principal investigator, Ospedale Sandro Pertini - ASL RM2- Rome- Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972736
- Sponsor's protocol ID
- Pertini04
- Acronym
- RODEO
- Status last verified
- May 2024
- First submitted
- 14 Nov 2016
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RadiatiOn Dose Among Different EndOvascular Procedures: the RODEO Study
- ClinicalTrials.gov ID
- NCT02972736
- Acronym / sponsor ID
- RODEO / Pertini04
- Conditions
- Radiation Injuries
- Keywords
- Radiation dose, percutaneous coronary intervention, Coronary, Interventional radiology, Electrophysiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,711 participants (actual)
- Lead sponsor
- Ospedale Sandro Pertini, RomaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interventional Cardiology | – | Radiation: Radiation dose expressed as DAPAll procedures performed by interventional cardiologists |
| Electrophysiology | – | Radiation: Radiation dose expressed as DAPAll procedures performed by electrophysiologists |
| Interventional Radiology | – | Radiation: Radiation dose expressed as DAPAll vascular and non vascular procedures performed by interventional radiologists |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All procedures with DAP data available
Key inclusion criteria (1 listed)
- All procedures for which DAP values are available
Key exclusion criteria (1 listed)
- Procedures without DAP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation dose expressed as DAP | Radiation | Electrophysiology, Interventional Cardiology, Interventional Radiology |
Primary outcome
Radiation dose expressed as DAP
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Sciahbasi, MD, PhD principal investigator
Ospedale Sandro Pertini - ASL RM2- Rome- Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Injuries, run by Ospedale Sandro Pertini, Roma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation dose expressed as DAP (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.