Patients Undergoing Invasive Cardiac ProceduresRADARNCT03605030
Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures
A study testing Novel Lead Based Armboard and Standard Armboard in people with Patients Undergoing Invasive Cardiac Procedures and Radiation Exposure, run by London Health Sciences Centre at 1 site in Canada.
Trial summary
The primary objective of this study is to determine if a novel lead-based arm board is effective at reducing radiation dose to the operator during invasive cardiac procedures. Secondary objectives are to measure effect on radiation dose to patient and total fluoroscopy (x-ray) time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Invasive Cardiac Procedures, Radiation Exposure
- What is being tested?
- Novel Lead Based Armboard and Standard Armboard
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2017to 30 May 2018
- Phase
- Interventional
- 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
Who may be able to join
- Age > 18
- Planned invasive cardiology procedure, cardiac catheterization with or without percutaneous coronary intervention (PCI), or PCI alone.
Who cannot join
- Inability to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures With a Novel Lead-Based Arm-Board
The primary objective of this study is to determine if a novel lead-based arm board is effective at reducing radiation dose to the operator during invasive cardiac procedures. Secondary objectives are to measure effect on radiation dose to patient and total fluoroscopy (x-ray) time.
- Being tested
- Novel Lead Based Armboard, Standard Armboard
- Keywords
- Cardiac Catheterization, Percutaneous Coronary Intervention, Radiation, Lead Shielding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Lead Based ArmboardDevice
Novel Lead Based Armboard
Standard ArmboardDevice
Standard Armboard (without lead)
| Study group | Role | What they receive |
|---|---|---|
| Novel Lead Based Armboard | Active comparator | Not described Receives: Device: Novel Lead Based Armboard |
| Standard Armboard | Placebo comparator | Not described Receives: Device: Standard Armboard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose (μSv) to the operator at the chest
Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.
Measured: At procedure completion
Radiation dose (μSv) to the operator at the forearm level
Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.
Measured: At procedure completion
Secondary outcomes (3)
Air kerma
Measured: At procedure completion
Dose area product
Measured: At procedure completion
Radiation dose to the patient
Measured: At procedure completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start29 May 2017
- Primary completion25 Jan 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Invasive Cardiac ProceduresStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canada
- Responsible party
- Principal investigator, Pallav Garg, London Health Sciences Centre
- Investigators
- Pallav Garg, MBBS, MSc, Principal investigator, London Health Sciences Centre, Western University, London, ON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605030
- Sponsor's protocol ID
- 108913
- Acronym
- RADAR
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures With a Novel Lead-Based Arm-Board
- ClinicalTrials.gov ID
- NCT03605030
- Acronym / sponsor ID
- RADAR / 108913
- Keywords
- Cardiac Catheterization, Percutaneous Coronary Intervention, Radiation, Lead Shielding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Collaborators
- Western University, Canada
- Study start
- 29 May 2017 (actual)
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 30 Jul 2018 (actual)
- 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.
The primary objective of this study is to determine if a novel lead-based arm board is effective at reducing radiation dose to the operator during invasive cardiac procedures. Secondary objectives are to measure effect on radiation dose to patient and total fluoroscopy (x-ray) time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel Lead Based Armboard | Active comparator | Device: Novel Lead Based Armboard |
| Standard Armboard | Placebo comparator | Device: Standard Armboard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18
- Planned invasive cardiology procedure, cardiac catheterization with or without percutaneous coronary intervention (PCI), or PCI alone.
Key exclusion criteria (1 listed)
- Inability to provide consent
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 |
|---|---|---|
| Novel Lead Based ArmboardNovel Lead Based Armboard | Device | Novel Lead Based Armboard |
| Standard ArmboardStandard Armboard (without lead) | Device | Standard Armboard |
Primary outcome
Radiation dose (μSv) to the operator at the chest
Time frame: At procedure completion
Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.
Radiation dose (μSv) to the operator at the forearm level
Time frame: At procedure completion
Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.
3 secondary outcomes
Air kerma
Time frame: At procedure completion
Dose area product
Time frame: At procedure completion
Radiation dose to the patient
Time frame: At procedure completion
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 30 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Pallav Garg, MBBS, MSc principal investigator
London Health Sciences Centre, Western University, London, ON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Lead Based Armboard and Standard Armboard in people with Patients Undergoing Invasive Cardiac Procedures and Radiation Exposure, run by London Health Sciences Centre at 1 site in Canada.
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 2 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 30 Jul 2018. 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 Canada. 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. Some participants in this study may receive a placebo. 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 (μSv) to the operator at the chest (time frame: At procedure completion). The study lists 2 primary outcomes in all. 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 30 Jul 2018.