Coronary Artery DiseaseOSCARNCT04945538
Scatter Radiation Exposure During Coronary Procedures - The Occupational SCAtter Radiation Registry
An observational study of Coronary Artery Disease, run by Paracelsus Medical University at 1 site in Austria.
Trial summary
During diagnostic and interventional coronary procedures scatter radiation exposure is recorded with live-dosimeters at pre-specified anatomic regions of operators and sterile assistants. Scatter radiation data is correlated with detailed Xray exposure data and technical details of the procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Scatter radiation exposure measurement
- How many people
- 2,000 participants
- Where
- 1 siteAustria
- Study dates
- 9 Jun 2021to 8 Sep 2025
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Two study populations have to be considered separately: 1. PDL Recordings: Study population: Interventional cardiologists regularly assigned to our Cath-labs working at the cath-lab table during the majority of their assignment. 2. Coronary procedures during which data is recorded: Study population: Patients with clinical indication for diagnostic or interventional coronary procedures, representing the classic cardiologic patient population with suspected or known coronary artery disease, acute coronary syndrome or heart valve dysfunction.
Who may be able to join
- Patient scheduled for coronary angiography
- Diagnostic procedure and PCI
- Acute and elective procedures
- Standard percutaneous coronary interventions (PCI) interventions
- Chronic total occlusion (CTO) interventions
- Set of at least 4 personal digital live dosimeters (PDL) worn by operator and sterile assistant for the entire duration of the procedure
- Staff (operators and assistants) instructed on PDL positioning prior to procedure
Who cannot join
- Less than 4 PDL present during the procedure
- Incomplete data recording by at least 1 PDL
- PDL data cannot be unambiguously assigned to a specific procedure or a specific anatomical recording site
- Exchange of operator or assistant during procedure without transfer of all PDL
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Paracelsus Medical University, Clinic II of Internal Medicine
Salzburg, 5020
Mathias C. Brandt, MD, +43-5-7255 ext. 58871, m.brandt@salk.at
Uta C. Hoppe, Prof.MD, +43-5-7255 ext. 25601, u.hoppe@salk.at
About this study
Official title: Quantification and Determinants of Occupational Xray Scatter Radiation Exposure of Operators and Assistants During Coronary Procedures - The Occupational SCAtter Radiation Registry
During diagnostic and interventional coronary procedures scatter radiation exposure is recorded with live-dosimeters at pre-specified anatomic regions of operators and sterile assistants. Scatter radiation data is correlated with detailed Xray exposure data and technical details of the procedure.
The purpose of the registry is:
- to establish scatter radiation reference values based on a large number of representative cath-lab procedures
- to identify technical and clinical factors predisposing for high scatter radiation exposure,
- to evaluate advanced radiation protection devices in clinical routine.
Read the detailed description
Patients scheduled for diagnostic or interventional coronary procedures provide written informed consent for participating in the observational OSCAR Registry. During the corresponding procedures, scatter radiation exposure of operators and sterile assistants is recorded using Unfors RaySafe i3 digital live dosimeters (Unfors RaySafe AB, Billdal, Sweden) at 3 locations of the operator (1-frontal head at eye level, 2-left lateral head, 3-below the left shoulder) and at 2 locations of the sterile assistant (1-left neck and 2-below the left shoulder).
Raw data is collected in a central database and correlated with patient properties (age, BMI) and detailed Xray exposure data:
- Total dose-area product (DAP, unit of measure: Gy*cm2)
- Number of Xray image series
- Number of Images
- Radiation duration (Unit of measure: Seconds)
- Air kinetic energy released per unit mass (Kerma) Technical details of the procedure
- Access site,
- Clinical setting: acute or elective
- Number of catheters used during procedure
- Number of guidewires used during procedure
- Number of stents implanted during procedure
- Cumulative stent length (Unit of measure: mm)
- Use of rotational imaging
- Use of intracoronary pressure-wire
- Use of optical coherence tomography (OCT)
- Presence of bypass-vessels
- Any occurrence of complications
The purpose of the trial is to establish a large foundation of intra-procedural scatter radiation data from representative coronary procedures procedures enabling our group to
- Establish scatter radiation reference values based on a large number of representative cath-lab procedures
- Identify technical and clinical factors predisposing for high staff scatter radiation exposure
- Evaluate advanced radiation protection devices in clinical routine.
This includes:
- Additional ceiling-suspended lead-shielding
- Ceiling-suspended radiation protection devices like the "Zero-Gravity"-System (TIDI Medical Products, Neenah, WI, USA)
- Patient lead-covers.
The study was submitted to and approved by the federal Ethics Committee Salzburg (reference number ECS 1069/2021).
- Conditions
- Coronary Artery Disease
- Being tested
- Scatter radiation exposure measurement
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scatter radiation exposure measurementOther
Scatter radiation exposure of the operator and sterile assistant is recorded with digital live dosimeters at 3 locations of the operator (frontal head at eye level, left lateral head, below the left shoulder) and at 2 locations of the sterile assistant (left neck and below the left shoulder)
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-procedural Xray scatter radiation exposure (µSv)
Xray scatter radiation dose recorded by 5 personal live dosimeters (3 allocated to the operator, 2 allocated to the sterile assistant).
Measured: Duration of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start9 Jun 2021
- Primary completion8 Aug 2025 (estimated)
- Study completion8 Sep 2025 (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 Coronary Artery DiseaseStudies 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
- 2,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Brandt, Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945538
- Sponsor's protocol ID
- ParacelsusMU
- Acronym
- OSCAR
- Status last verified
- Nov 2023
- First submitted
- 21 Jun 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brandt M, Prinz E, Schernthaner C, Kraus J, Wintersteller W, Hammerer M, Strohmer B, Lichtenauer M, Motloch L, Hoppe UC, Nairz O. Advanced Radiation Protection in PCI and Diagnostic Procedures With a Ceiling-Suspended Radiation Protection System-Data From the OSCAR Registry. J Am Coll Cardiol 2021; 78 (19_Supplement_S): B63-B64
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification and Determinants of Occupational Xray Scatter Radiation Exposure of Operators and Assistants During Coronary Procedures - The Occupational SCAtter Radiation Registry
- ClinicalTrials.gov ID
- NCT04945538
- Acronym / sponsor ID
- OSCAR / ParacelsusMU
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 8 Aug 2025 (estimated)
- Study completion
- 8 Sep 2025 (estimated)
- First posted
- 30 Jun 2021 (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.
During diagnostic and interventional coronary procedures scatter radiation exposure is recorded with live-dosimeters at pre-specified anatomic regions of operators and sterile assistants. Scatter radiation data is correlated with detailed Xray exposure data and technical details of the procedure.
The purpose of the registry is:
- to establish scatter radiation reference values based on a large number of representative cath-lab procedures
- to identify technical and clinical factors predisposing for high scatter radiation exposure,
- to evaluate advanced radiation protection devices in clinical routine.
Detailed description
Patients scheduled for diagnostic or interventional coronary procedures provide written informed consent for participating in the observational OSCAR Registry. During the corresponding procedures, scatter radiation exposure of operators and sterile assistants is recorded using Unfors RaySafe i3 digital live dosimeters (Unfors RaySafe AB, Billdal, Sweden) at 3 locations of the operator (1-frontal head at eye level, 2-left lateral head, 3-below the left shoulder) and at 2 locations of the sterile assistant (1-left neck and 2-below the left shoulder).
Raw data is collected in a central database and correlated with patient properties (age, BMI) and detailed Xray exposure data:
- Total dose-area product (DAP, unit of measure: Gy*cm2)
- Number of Xray image series
- Number of Images
- Radiation duration (Unit of measure: Seconds)
- Air kinetic energy released per unit mass (Kerma) Technical details of the procedure
- Access site,
- Clinical setting: acute or elective
- Number of catheters used during procedure
- Number of guidewires used during procedure
- Number of stents implanted during procedure
- Cumulative stent length (Unit of measure: mm)
- Use of rotational imaging
- Use of intracoronary pressure-wire
- Use of optical coherence tomography (OCT)
- Presence of bypass-vessels
- Any occurrence of complications
The purpose of the trial is to establish a large foundation of intra-procedural scatter radiation data from representative coronary procedures procedures enabling our group to
- Establish scatter radiation reference values based on a large number of representative cath-lab procedures
- Identify technical and clinical factors predisposing for high staff scatter radiation exposure
- Evaluate advanced radiation protection devices in clinical routine.
This includes:
- Additional ceiling-suspended lead-shielding
- Ceiling-suspended radiation protection devices like the "Zero-Gravity"-System (TIDI Medical Products, Neenah, WI, USA)
- Patient lead-covers.
The study was submitted to and approved by the federal Ethics Committee Salzburg (reference number ECS 1069/2021).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Two study populations have to be considered separately: 1. PDL Recordings: Study population: Interventional cardiologists regularly assigned to our Cath-labs working at the cath-lab table during the majority of their assignment. 2. Coronary procedures during which data is recorded: Study population: Patients with clinical indication for diagnostic or interventional coronary procedures, representing the classic cardiologic patient population with suspected or known coronary artery disease, acute coronary syndrome or heart valve dysfunction.
Key inclusion criteria (7 listed)
- Patient scheduled for coronary angiography
- Diagnostic procedure and PCI
- Acute and elective procedures
- Standard percutaneous coronary interventions (PCI) interventions
- Chronic total occlusion (CTO) interventions
Key exclusion criteria (4 listed)
- Less than 4 PDL present during the procedure
- Incomplete data recording by at least 1 PDL
- PDL data cannot be unambiguously assigned to a specific procedure or a specific anatomical recording site
- Exchange of operator or assistant during procedure without transfer of all PDL
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 |
|---|---|---|
| Scatter radiation exposure measurementScatter radiation exposure of the operator and sterile assistant is recorded with digital live dosimeters at 3 locations of the operator (frontal head at eye level, left lateral head, below the left shoulder) and at 2 locations of the sterile assistant (left neck and below the left shoulder) | Other | – |
Primary outcome
Intra-procedural Xray scatter radiation exposure (µSv)
Time frame: Duration of procedure
Xray scatter radiation dose recorded by 5 personal live dosimeters (3 allocated to the operator, 2 allocated to the sterile assistant).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- BackgroundBrandt M, Prinz E, Schernthaner C, Kraus J, Wintersteller W, Hammerer M, Strohmer B, Lichtenauer M, Motloch L, Hoppe UC, Nairz O. Advanced Radiation Protection in PCI and Diagnostic Procedures With a Ceiling-Suspended Radiation Protection System-Data From the OSCAR Registry. J Am Coll Cardiol 2021; 78 (19_Supplement_S): B63-B64
- Austrian Society of Cardiology 2021 PosterLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
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 Coronary Artery Disease, run by Paracelsus Medical University at 1 site in Austria.
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 7 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 18 Nov 2023. 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 Austria. 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 Mathias C. Brandt, MD (+43-5-7255 ext. 58871, m.brandt@salk.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-procedural Xray scatter radiation exposure (µSv) (time frame: Duration of procedure). 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 NCT04945538, 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 18 Nov 2023.