RADIATION PROTECTion With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention
NCT ID: NCT02128035
Last Updated: 2015-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
230 participants
INTERVENTIONAL
2013-12-31
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields
NCT01839162
Reduction of Catheterization Radiation Exposure Pad
NCT03139968
Coagulation Profile in Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention
NCT05336669
The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients With Coronary Artery Disease
NCT01508663
Platelet Function Monitoring in Patients With Acute Myocardial Infarction
NCT01353261
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Without Lead Shield
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.
No interventions assigned to this group
With Lead Shield
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.
With Lead Shield
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
With Lead Shield
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Previous inclusion in RADIATION PROTECT trial
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
McMaster University
OTHER
Population Health Research Institute
OTHER
Dr. Sanjit S. Jolly
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Sanjit S. Jolly
Interventional Cardiologist, Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sanjit S Jolly, MD
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences, McMaster University
Ashraf Al Azzoni, MD
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hamilton Health Sciences
Hamilton, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Project Number 12-520
Identifier Type: OTHER
Identifier Source: secondary_id
RADIATION PROTECT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.