AtherosclerosisNCT01469195
A Lead Rectangle to Lower the Operator's Radiation Exposure
An observational study of Atherosclerosis and Coronary Occlusion, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
During fluoroscopic imaging, diagnostic information is carried in the primary beam. These high intensity X-rays are the chief hazard to the patient. Lower energy scattered radiation deviates in all directions from the patient. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atherosclerosis, Coronary Occlusion, Coronary Artery Disease
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Jul 2012
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: elective or acute coronary syndrome patients who go through percutaneous coronary intervention at one tertiary centre
Who may be able to join
- patients referred for an elective (non emergent) - radial access approach for coronary angioplasty.
- patients with angina pectoris or acute coronary syndrome, which are hemodynamically stable, will be included.
- Age 18-75.
Who cannot join
- Urgent/Emergent procedures (ST elevation myocardial infarction, suspected LM disease, low Ejection fraction <35%, patients in heart failure - NYHA class III, IV).
- Any situation that there is higher chance (over 10%) of switching to a femoral access approach (like weak radial pulse, low blood pressure <90 mmHg, failed radial access in the past) .
- Significant valve disease like; severe aortic stenosis, severe mitral regurgitation.
- Pregnancy or women in child bearing age.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook health sciences centre
Toronto, Ontario, M4N 3M5
Bradley H Strauss, MD, PhD, 416480-6066, bradley.strauss@sunnybrook.ca
About this study
Official title: A Lead Rectangle to Lower the Radiation Exposure for Operators Who Uses Radial Approach in Coronary Procedures.
During fluoroscopic imaging, diagnostic information is carried in the primary beam. These high intensity X-rays are the chief hazard to the patient. Lower energy scattered radiation deviates in all directions from the patient. Despite typical precautions (i.e., hanging a lead shield between the patient and the operator), many operators will be exposed to high radiation dose (higher than the permitted 50 miliS per year), this long term radiation exposure may result in stochastic and deterministic effects. The purpose of this study was to test the hypothesis that a non disposable radiation protection drape (that will cover the lower part of the patient) could help minimize the radiation scattered from the patient to the operator. In a procedure done through the Radial approach, there is a large portion of the patients (from the umbilicus and down) that is a source of scatter radiation to the operator. This portion can be covered with a lead rectangle. A non disposable, lead drape of uniform thickness will be inserted into a sterile nylon bag and will be used during fluoroscopic and cineangiography coronary angioplasty procedures. The lead drapes will cover the femoral puncture site. The widths and length of the drape is 50-60cm and 100 cm respectively and was shown not to hinder the field of radiation needed for fluoroscopy and cineangiography. (The upper border of the lead is under the patient's umbilicus and was shown not to interfere with the radiation field needed for angiography or angioplasty).
The Investigators anticipate that the study will show a significant reduction in radiation exposure and hence reduce the radiation hazard to the operator.
Read the detailed description
The Investigators tested the hypothesis on a Phantom that contain bones and tissue that simulate human tissue. The above phantom is used in the oncology department for testing radiation protocols delivered to patients. Those preliminary testing showed that a lead rectangle decreased significantly the radiation scattered towards the operators and personnel in the catheterization laboratory. In all chosen places whether 40 or 100 cm from the radiation beam - The Investigators detected a significant reduction in scattered radiation. The significant reduction in these experiments is attributed to the location the Investigators choose but also to the size of the lead drape 100 X60 cm which give a large area of protection. From simple geometric calculations it's understandable that the zone or volume of radiation protection become much larger further away from the lead rectangle.Patients who are admitted for an elective PCI procedure ( or stable ACS patients) will be ask to participate in the study and sign an informed consent. All the procedure will be as standard of care, after cleaning the right or left arm, and the groin a sterile towel will cover the groin, on top of the sterile towel the lead rectangle (that by itself will be inserted to a sterile nylon bag) will be put over to cover the area from the umbilicus and down.
(In case that the radial approach will fail and femoral approach will be needed, it is easy to remove the lead rectangle while keeping sterile field in the groin area). Few dosimeters will be used to assess radiation exposure, two underneath the lead apron, one on top, and two dosimeters for the operator (two detecting the radiation exposure in the neck area).
The Investigators will approach patients in whom a long procedure time and higher radiation exposure are anticipated (like patients with chronic total occlusion, heavily calcified or tortuous coronary arteries). In those, the fluoroscopy time on average, is longer than usual.
A total of 50 patients will be recruited (based on the Investigators preliminary radiation testing on the phantom and the results of Politi et al). In 25 patients a lead rectangle will be used on top of the regular protection (personal lead suit, leaded glass shield), in 25 patients only regular protection for the operators.
- Conditions
- Atherosclerosis, Coronary Occlusion, Coronary Artery Disease
- Keywords
- lead rectangle, radiation exposure, operators, radial approach, coronary procedures, percutaneous coronary intervention
- Medical subject headings
- Atherosclerosis, Coronary Occlusion, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A - No lead protection | Patients who are admitted for an elective percutaneous coronary intervention procedure ( or stable acute coronary syndrome patients) will be ask to participate in the study and sign an informed consent (see inclusions and exclusions).The Investigators will approach patients in whom a long procedure time and higher radiation exposure are anticipated (like patients with chronic total occlusion, heavily calcified or tortuous coronary arteries). In those, the fluoroscopy time on average, is longer than usual. In group A - no lead protection will be used. | |
| Group B plus lead protection | Patients who are admitted for an elective percutaneous coronary intervention procedure ( or stable acute coronary syndrome patients) will be ask to participate in the study and sign an informed consent (see inclusions and exclusions).The Investigators will approach patients in whom a long procedure time and higher radiation exposure are anticipated (like patients with chronic total occlusion, heavily calcified or tortuous coronary arteries). In those, the fluoroscopy time on average, is longer than usual. In group B - lead protection will be used from the umbilicus and down. |
What is being measured
The primary outcome is the main question the study is designed to answer.
scattered radiation reduction with lead rectangle protection Vs. no protection at distance of 40-100 cm from the radiation beam
The Investigators will use "Inlight" (Landauer) dosimeters that are sensitive and can be read over and over to give the differences in scattered radiation, (with or without the lead rectangle). these dosimeters will be read Immediately at the end of the procedure. The investigators will look for the difference in the readings between patients that had the lead rectangle on to patients without the lead rectangle.
Measured: Outcome measure is assessed same day immediately after the procedure (recording the dose of radiation detected by the dosimeters) participants will be followed for the duration of hospital stay, an expected average of 2-4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
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 AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley H Strauss, MD, PhD, Principal investigator, Sunnybrook Health Sciences Centre, Schulich Heart program Devision of Cardiology Toronto Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469195
- Sponsor's protocol ID
- RAD410OSH
- Status last verified
- Nov 2011
- First submitted
- 31 Oct 2011
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Politi L, Biondi-Zoccai G, Nocetti L, Costi T, Monopoli D, Rossi R, Sgura F, Modena MG, Sangiorgi GM. Reduction of scatter radiation during transradial percutaneous coronary angiography: a randomized trial using a lead-free radiation shield. Catheter Cardiovasc Interv. 2012 Jan 1;79(1):97-102. doi: 10.1002/ccd.22947. Epub 2011 Apr 25.
PubMed 21520391
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Lead Rectangle to Lower the Radiation Exposure for Operators Who Uses Radial Approach in Coronary Procedures.
- ClinicalTrials.gov ID
- NCT01469195
- Acronym / sponsor ID
- RAD410OSH
- Conditions
- Atherosclerosis, Coronary Occlusion, Coronary Artery Disease
- Keywords
- lead rectangle, radiation exposure, operators, radial approach, coronary procedures, percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 10 Nov 2011 (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.
During fluoroscopic imaging, diagnostic information is carried in the primary beam. These high intensity X-rays are the chief hazard to the patient. Lower energy scattered radiation deviates in all directions from the patient. Despite typical precautions (i.e., hanging a lead shield between the patient and the operator), many operators will be exposed to high radiation dose (higher than the permitted 50 miliS per year), this long term radiation exposure may result in stochastic and deterministic effects. The purpose of this study was to test the hypothesis that a non disposable radiation protection drape (that will cover the lower part of the patient) could help minimize the radiation scattered from the patient to the operator. In a procedure done through the Radial approach, there is a large portion of the patients (from the umbilicus and down) that is a source of scatter radiation to the operator. This portion can be covered with a lead rectangle. A non disposable, lead drape of uniform thickness will be inserted into a sterile nylon bag and will be used during fluoroscopic and cineangiography coronary angioplasty procedures. The lead drapes will cover the femoral puncture site. The widths and length of the drape is 50-60cm and 100 cm respectively and was shown not to hinder the field of radiation needed for fluoroscopy and cineangiography. (The upper border of the lead is under the patient's umbilicus and was shown not to interfere with the radiation field needed for angiography or angioplasty).
The Investigators anticipate that the study will show a significant reduction in radiation exposure and hence reduce the radiation hazard to the operator.
Detailed description
The Investigators tested the hypothesis on a Phantom that contain bones and tissue that simulate human tissue. The above phantom is used in the oncology department for testing radiation protocols delivered to patients. Those preliminary testing showed that a lead rectangle decreased significantly the radiation scattered towards the operators and personnel in the catheterization laboratory. In all chosen places whether 40 or 100 cm from the radiation beam - The Investigators detected a significant reduction in scattered radiation. The significant reduction in these experiments is attributed to the location the Investigators choose but also to the size of the lead drape 100 X60 cm which give a large area of protection. From simple geometric calculations it's understandable that the zone or volume of radiation protection become much larger further away from the lead rectangle.Patients who are admitted for an elective PCI procedure ( or stable ACS patients) will be ask to participate in the study and sign an informed consent. All the procedure will be as standard of care, after cleaning the right or left arm, and the groin a sterile towel will cover the groin, on top of the sterile towel the lead rectangle (that by itself will be inserted to a sterile nylon bag) will be put over to cover the area from the umbilicus and down.
(In case that the radial approach will fail and femoral approach will be needed, it is easy to remove the lead rectangle while keeping sterile field in the groin area). Few dosimeters will be used to assess radiation exposure, two underneath the lead apron, one on top, and two dosimeters for the operator (two detecting the radiation exposure in the neck area).
The Investigators will approach patients in whom a long procedure time and higher radiation exposure are anticipated (like patients with chronic total occlusion, heavily calcified or tortuous coronary arteries). In those, the fluoroscopy time on average, is longer than usual.
A total of 50 patients will be recruited (based on the Investigators preliminary radiation testing on the phantom and the results of Politi et al). In 25 patients a lead rectangle will be used on top of the regular protection (personal lead suit, leaded glass shield), in 25 patients only regular protection for the operators.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - No lead protection | – | –Patients who are admitted for an elective percutaneous coronary intervention procedure ( or stable acute coronary syndrome patients) will be ask to participate in the study and sign an informed consent (see inclusions and exclusions).The Investigators will approach patients in whom a long procedure time and higher radiation exposure are anticipated (like patients with chronic total occlusion, heavily calcified or tortuous coronary arteries). In those, the fluoroscopy time on average, is longer than usual. In group A - no lead protection will be used. |
| Group B plus lead protection | – | –Patients who are admitted for an elective percutaneous coronary intervention procedure ( or stable acute coronary syndrome patients) will be ask to participate in the study and sign an informed consent (see inclusions and exclusions).The Investigators will approach patients in whom a long procedure time and higher radiation exposure are anticipated (like patients with chronic total occlusion, heavily calcified or tortuous coronary arteries). In those, the fluoroscopy time on average, is longer than usual. In group B - lead protection will be used from the umbilicus and down. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elective or acute coronary syndrome patients who go through percutaneous coronary intervention at one tertiary centre
Key inclusion criteria (3 listed)
- patients referred for an elective (non emergent) - radial access approach for coronary angioplasty.
- patients with angina pectoris or acute coronary syndrome, which are hemodynamically stable, will be included.
- Age 18-75.
Key exclusion criteria (4 listed)
- Urgent/Emergent procedures (ST elevation myocardial infarction, suspected LM disease, low Ejection fraction <35%, patients in heart failure - NYHA class III, IV).
- Any situation that there is higher chance (over 10%) of switching to a femoral access approach (like weak radial pulse, low blood pressure <90 mmHg, failed radial access in the past) .
- Significant valve disease like; severe aortic stenosis, severe mitral regurgitation.
- Pregnancy or women in child bearing age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
scattered radiation reduction with lead rectangle protection Vs. no protection at distance of 40-100 cm from the radiation beam
Time frame: Outcome measure is assessed same day immediately after the procedure (recording the dose of radiation detected by the dosimeters) participants will be followed for the duration of hospital stay, an expected average of 2-4 days.
The Investigators will use "Inlight" (Landauer) dosimeters that are sensitive and can be read over and over to give the differences in scattered radiation, (with or without the lead rectangle). these dosimeters will be read Immediately at the end of the procedure. The investigators will look for the difference in the readings between patients that had the lead rectangle on to patients without the lead rectangle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
- Background: PubMed 21520391Politi L, Biondi-Zoccai G, Nocetti L, Costi T, Monopoli D, Rossi R, Sgura F, Modena MG, Sangiorgi GM. Reduction of scatter radiation during transradial percutaneous coronary angiography: a randomized trial using a lead-free radiation shield. Catheter Cardiovasc Interv. 2012 Jan 1;79(1):97-102. doi: 10.1002/ccd.22947. Epub 2011 Apr 25.
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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.
Bradley H Strauss, MD, PhD principal investigator
Sunnybrook Health Sciences Centre, Schulich Heart program Devision of Cardiology Toronto Ontario, Canada
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 Atherosclerosis and Coronary Occlusion, run by Sunnybrook 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Nov 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bradley H Strauss, MD PhD (416 480 6066, bradley.strauss@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scattered radiation reduction with lead rectangle protection Vs. no protection at distance of 40-100 cm from the radiation beam (time frame: Outcome measure is assessed same day immediately after the procedure (recording the dose of radiation detected by the dosimeters) participants will be followed for the duration of hospital stay, an expected average of 2-4 days.). 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 NCT01469195, 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 10 Nov 2011.