Scatter Radiation Exposure During Coronary Procedures - The Occupational SCAtter Radiation Registry (OSCAR)

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:

1. to establish scatter radiation reference values based on a large number of representative cath-lab procedures
2. to identify technical and clinical factors predisposing for high scatter radiation exposure,
3. to evaluate advanced radiation protection devices in clinical routine.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Scatter radiation exposure measurement

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

1. Establish scatter radiation reference values based on a large number of representative cath-lab procedures
2. Identify technical and clinical factors predisposing for high staff scatter radiation exposure
3. 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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Mathias C. Brandt, MD; Phone Number: 58871 +43-5-7255; Email: m.brandt@salk.at
• Study Contact Backup: Name: Uta C. Hoppe, Prof.MD.; Phone Number: 25601 +43-5-7255; Email: u.hoppe@salk.at

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Recruiting
    • Paracelsus Medical University, Clinic II of Internal Medicine
    • Contact: Mathias C. Brandt, MD; Phone Number: 58871 +43-5-7255; Email: m.brandt@salk.at
    • Contact: Uta C. Hoppe, Prof.MD; Phone Number: 25601 +43-5-7255; Email: u.hoppe@salk.at
    • Principal Investigator: Mathias C. Brandt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Duration of procedure

Collaborators and Investigators

• Sponsor: Paracelsus Medical University

Publications and helpful links

General 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

Helpful Links

• Austrian Society of Cardiology 2021 Poster

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Estimated): August 8, 2025
• Study Completion (Estimated): September 8, 2025

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: ParacelsusMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No