Acute Coronary SyndromesNCT02128035
RADIATION PROTECTion With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention
A study testing With Lead Shield in people with Acute Coronary Syndromes, run by Dr. Sanjit S. Jolly at 1 site in Canada.
Trial summary
RADIATION PROTECT is a randomized, controlled trial of patients undergoing coronary angiography or PCI with or without a pelvic lead shield. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- With Lead Shield
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Jun 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient referred for coronary angiography or Percutaneous Coronary Intervention (PCI)
Who cannot join
- Age ≤ 18 years
- Previous inclusion in RADIATION PROTECT trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiation Protection With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention, a Randomized Controlled Trial
RADIATION PROTECT is a randomized, controlled trial of patients undergoing coronary angiography or PCI with or without a pelvic lead shield. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.
It is hypothesized that routine use of the pelvic lead shield and radiation protection cap during these procedures will reduce the amount of radiation in which the interventional cardiologists get exposed.
Read the detailed description
Patients referred for coronary angiography or PCI will be randomized to undergo their procedure with or without the pelvic lead shield and the operator will wear a radiation protection cap.
Clinical efficacy will be assessed based on the total radiation dose that the interventional cardiologist got exposed to as well as a secondary outcome measuring the total radiation exposure dose per minute.
- Conditions
- Acute Coronary Syndromes
- Being tested
- With Lead Shield
- Keywords
- radiation protection, interventional cardiologist, percutaneous coronary intervention (PCI), angiography, lead shield
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With Lead ShieldProcedure or surgery
A pelvic lead shield will be draped on patient from umbilicus to knees.
Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.
| Study group | Role | What they receive |
|---|---|---|
| Without Lead Shield | No intervention | All routine measures to reduce radiation exposure (including lead aprons, lead collar, lead lenses, movable ceiling suspended lead shield with a long lead skirt attached to its lower margin) will be used as done routinely and will be left to the operators' discretion. The LEAD SHIELD will not be used in this group. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures. |
| With Lead Shield | Experimental | All routine measures to reduce radiation exposure (including lead aprons, lead collar, lead lenses, movable ceiling suspended lead shield with a long lead skirt attached to its lower margin) will be used as done routinely and will be left to the operators' discretion.
In this group, a LEAD SHIELD will be used. The Pelvic lead shield will be draped on patient from umbilicus to knees.
Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures. Receives: Procedure: With Lead Shield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Radiation Dose
- The total radiation dose that the interventional cardiologist got exposed to as read by dosimeters (µSv) at left breast.
- The difference between both groups in radiation dose that the interventional cardiologist got exposed to divided by Air Kerma (µSv/mGy).
- For the radiation protection cap, the primary outcome is the difference between total radiation dose as measured by two dosimeters (µSv) at left temporal region of the head of the interventional cardiologist (one on the outside of the radiation protection cap and the other one on the inside of the cap).
Measured: Duration of Procedure (an expected average of 30 minutes)
Secondary outcomes (1)
Radiation Exposure Dose per minute
The difference between both groups in radiation exposure dose per minute (µSv /min) at left breast and left temporal region.
Measured: Duration of Procedure (an expected average of 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Sanjit S. Jolly
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Population Health Research Institute
- Responsible party
- Sponsor-investigator, Dr. Sanjit S. Jolly, Population Health Research Institute
- Investigators
- Sanjit S Jolly, MD, Principal investigator, Hamilton Health Sciences, McMaster UniversityAshraf Al Azzoni, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128035
- Sponsor's protocol ID
- RADIATION PROTECT
- Other IDs
- Project Number 12-520
- Status last verified
- Apr 2015
- First submitted
- 20 Dec 2012
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Alazzoni A, Gordon CL, Syed J, Natarajan MK, Rokoss M, Schwalm JD, Mehta SR, Sheth T, Valettas N, Velianou J, Pandie S, Al Khdair D, Tsang M, Meeks B, Colbran K, Waller E, Fu Lee S, Marsden T, Jolly SS. Randomized Controlled Trial of Radiation Protection With a Patient Lead Shield and a Novel, Nonlead Surgical Cap for Operators Performing Coronary Angiography or Intervention. Circ Cardiovasc Interv. 2015 Aug;8(8):e002384. doi: 10.1161/CIRCINTERVENTIONS.115.002384.
PubMed 26253734
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Protection With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02128035
- Acronym / sponsor ID
- RADIATION PROTECT
- Conditions
- Acute Coronary Syndromes
- Keywords
- radiation protection, interventional cardiologist, percutaneous coronary intervention (PCI), angiography, lead shield
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Dr. Sanjit S. JollyUniversity, hospital or other
- Collaborators
- McMaster University, Population Health Research Institute
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 May 2014 (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 PROTECT is a randomized, controlled trial of patients undergoing coronary angiography or PCI with or without a pelvic lead shield. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.
It is hypothesized that routine use of the pelvic lead shield and radiation protection cap during these procedures will reduce the amount of radiation in which the interventional cardiologists get exposed.
Detailed description
Patients referred for coronary angiography or PCI will be randomized to undergo their procedure with or without the pelvic lead shield and the operator will wear a radiation protection cap.
Clinical efficacy will be assessed based on the total radiation dose that the interventional cardiologist got exposed to as well as a secondary outcome measuring the total radiation exposure dose per minute.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without Lead Shield | No intervention | –All routine measures to reduce radiation exposure (including lead aprons, lead collar, lead lenses, movable ceiling suspended lead shield with a long lead skirt attached to its lower margin) will be used as done routinely and will be left to the operators' discretion. The LEAD SHIELD will not be used in this group. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures. |
| With Lead Shield | Experimental | Procedure: With Lead ShieldAll routine measures to reduce radiation exposure (including lead aprons, lead collar, lead lenses, movable ceiling suspended lead shield with a long lead skirt attached to its lower margin) will be used as done routinely and will be left to the operators' discretion. In this group, a LEAD SHIELD will be used. The Pelvic lead shield will be draped on patient from umbilicus to knees. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient referred for coronary angiography or Percutaneous Coronary Intervention (PCI)
Key exclusion criteria (2 listed)
- Age ≤ 18 years
- Previous inclusion in RADIATION PROTECT trial
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 |
|---|---|---|
| With Lead ShieldA pelvic lead shield will be draped on patient from umbilicus to knees. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures. | Procedure or surgery | With Lead Shield |
Primary outcome
Total Radiation Dose
Time frame: Duration of Procedure (an expected average of 30 minutes)
1. The total radiation dose that the interventional cardiologist got exposed to as read by dosimeters (µSv) at left breast. 2. The difference between both groups in radiation dose that the interventional cardiologist got exposed to divided by Air Kerma (µSv/mGy). 3. For the radiation protection cap, the primary outcome is the difference between total radiation dose as measured by two dosimeters (µSv) at left temporal region of the head of the interventional cardiologist (one on the outside of the radiation protection cap and the other one on the inside of the cap).
1 secondary outcome
Radiation Exposure Dose per minute
Time frame: Duration of Procedure (an expected average of 30 minutes)
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 28 Apr 2015.
- Derived from this study: PubMed 26253734Alazzoni A, Gordon CL, Syed J, Natarajan MK, Rokoss M, Schwalm JD, Mehta SR, Sheth T, Valettas N, Velianou J, Pandie S, Al Khdair D, Tsang M, Meeks B, Colbran K, Waller E, Fu Lee S, Marsden T, Jolly SS. Randomized Controlled Trial of Radiation Protection With a Patient Lead Shield and a Novel, Nonlead Surgical Cap for Operators Performing Coronary Angiography or Intervention. Circ Cardiovasc Interv. 2015 Aug;8(8):e002384. doi: 10.1161/CIRCINTERVENTIONS.115.002384.
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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.
Sanjit S Jolly, MD principal investigator
Hamilton Health Sciences, McMaster University
Ashraf Al Azzoni, MD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With Lead Shield in people with Acute Coronary Syndromes, run by Dr. Sanjit S. Jolly 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 1 inclusion and 2 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 28 Apr 2015. 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. 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?
Total Radiation Dose (time frame: Duration of Procedure (an expected average of 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128035, which also lists 1 linked publication.
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 28 Apr 2015.