Radiation ExposureRADIANTNCT01974453
RAdiation Dose In percutANeuos Coronary Procedures Through Transradial Approach (RADIANT Observational Study)
An observational study of Radiation Exposure, run by Ospedale Sandro Pertini, Roma at 1 site in Italy.
Trial summary
Radiation issue during percutaneous coronary interventions is an important issue for operators due to the long term stochastic risk of cancer induction, but is often under-evaluated. Many factors may be associated with the radiation dose adsorbed by operators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- Radiation dose
- Type of treatment
- Surgery or procedure
- How many people
- 2,028 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2012to Feb 2016
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medical operators that performe diagnostic and interventional coronary procedures
Who may be able to join
- All patients who underwent to percutaneous coronary diagnostic or interventional procedures
Who cannot join
- hemodynamic instability, age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Radiation issue during percutaneous coronary interventions is an important issue for operators due to the long term stochastic risk of cancer induction, but is often under-evaluated. Many factors may be associated with the radiation dose adsorbed by operators. In particular the most important are the position taken by the operator, the use of dedicated X-ray shield and the duration of the procedure. However other factors (as operator height or the angulation of the radiation tube) might have some important effects but are often under-evaluated .
Aim of our observational study is to evaluate the most important determinants of the radiation dose adsorbed by operators during different coronary procedures (diagnostic coronary angiography or percutaneous coronary interventions) and through different vascular accesses (right or left transradial approach or transfemoral approach).
Read more
All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this observational study.
Each operator will be equipped with dedicated dosimeters placed at left wrist, at thorax level outside the lead apron and at head level to evaluate the radiation dose at crystalline. Effective doses delivered to patients will be expressed as dose area product (DAP) and measured in Gycm2.
- Conditions
- Radiation Exposure
- Being tested
- Radiation dose
- Keywords
- Radiation dose, transradial approach, percutaneous coronary interventions, coronary angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation doseRadiation
Radiation dose adsorbed by operators
| Study group | Role | What they receive |
|---|---|---|
| Right transradial | Procedures performed through right transradial approach Receives: Radiation: Radiation dose | |
| Left transradial | Procedures performed through left transradial approach Receives: Radiation: Radiation dose | |
| Femoral | Procedures performed through transfemoral approach Receives: Radiation: Radiation dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Dose adsorbed by operators
Radiation Dose adsorbed by operators
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startAug 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies 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
- Prospective
- Enrolment
- 2,028 participants (actual)
- Target duration
- 1 Day
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974453
- Sponsor's protocol ID
- Pertini3
- Acronym
- RADIANT
- Status last verified
- Apr 2017
- First submitted
- 26 Oct 2013
- Last updated
- 6 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAdiation Dose In percutANeuos Coronary Procedures Through Transradial Approach (RADIANT Observational Study)
- ClinicalTrials.gov ID
- NCT01974453
- Acronym / sponsor ID
- RADIANT / Pertini3
- Conditions
- Radiation Exposure
- Keywords
- Radiation dose, transradial approach, percutaneous coronary interventions, coronary angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,028 participants (actual)
- Lead sponsor
- Ospedale Sandro Pertini, RomaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Nov 2013 (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.
Radiation issue during percutaneous coronary interventions is an important issue for operators due to the long term stochastic risk of cancer induction, but is often under-evaluated. Many factors may be associated with the radiation dose adsorbed by operators. In particular the most important are the position taken by the operator, the use of dedicated X-ray shield and the duration of the procedure. However other factors (as operator height or the angulation of the radiation tube) might have some important effects but are often under-evaluated .
Aim of our observational study is to evaluate the most important determinants of the radiation dose adsorbed by operators during different coronary procedures (diagnostic coronary angiography or percutaneous coronary interventions) and through different vascular accesses (right or left transradial approach or transfemoral approach).
All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this observational study.
Each operator will be equipped with dedicated dosimeters placed at left wrist, at thorax level outside the lead apron and at head level to evaluate the radiation dose at crystalline. Effective doses delivered to patients will be expressed as dose area product (DAP) and measured in Gycm2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Right transradial | – | Radiation: Radiation doseProcedures performed through right transradial approach |
| Left transradial | – | Radiation: Radiation doseProcedures performed through left transradial approach |
| Femoral | – | Radiation: Radiation doseProcedures performed through transfemoral approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical operators that performe diagnostic and interventional coronary procedures
Key inclusion criteria (1 listed)
- All patients who underwent to percutaneous coronary diagnostic or interventional procedures
Key exclusion criteria (1 listed)
- hemodynamic instability, age <18 years
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 doseRadiation dose adsorbed by operators | Radiation | Femoral, Left transradial, Right transradial |
Primary outcome
Radiation Dose adsorbed by operators
Time frame: Periprocedural
Radiation Dose adsorbed by operators
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 6 Apr 2017.
Related trials for Radiation Exposure
Not yet recruitingObservational study
Impact of Chronic MICROplastic Exposure on RADiotherapy of Head and Neck Cancer Patients: Clinical and Translational Oncology Study:
Head and Neck Cancer, Microplastic Exposure
Active, not recruiting
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
RecruitingObservational study
Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study
Operator Radiation Exposure
Recruiting
Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
RecruitingPhase 3
Using an Artificial Intelligence (AI) Tool for Melanoma Diagnosis
Malignant Melanoma of Skin, Other and Unspecified Malignant Neoplasm of Skin
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Exposure, run by Ospedale Sandro Pertini, Roma at 1 site in Italy.
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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 adsorbed by operators (time frame: Periprocedural). 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 6 Apr 2017.