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

Sponsor

Paracelsus Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04945538

Collaborator

(none)

750

Enrollment

Location

Anticipated Duration (Months)

31.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	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

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

750 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Quantification and Determinants of Occupational Xray Scatter Radiation Exposure of Operators and Assistants During Coronary Procedures - The Occupational SCAtter Radiation Registry

Actual Study Start Date :

Jun 9, 2021

Anticipated Primary Completion Date :

Jun 8, 2023

Anticipated Study Completion Date :

Jun 8, 2023

Outcome Measures

Primary Outcome Measures

Intra-procedural Xray scatter radiation exposure (µSv) [Duration of procedure]
Xray scatter radiation dose recorded by 5 personal live dosimeters (3 allocated to the operator, 2 allocated to the sterile assistant).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Paracelsus Medical University, Clinic II of Internal Medicine	Salzburg		Austria	5020

Sponsors and Collaborators

Paracelsus Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Austrian Society of Cardiology 2021 Poster

Publications

None provided.

Responsible Party:

Mathias Brandt, MD, Senior Physician, Principal Investigator, Paracelsus Medical University

ClinicalTrials.gov Identifier:

NCT04945538

Other Study ID Numbers:

ParacelsusMU

First Posted:

Jun 30, 2021

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Jun 30, 2021