NCT04945538

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:

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

4.2 years

First QC Date

June 21, 2021

Last Update Submit

November 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paracelsus Medical University, Clinic II of Internal Medicine

Salzburg, 5020, Austria

RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Mathias C. Brandt, MD

CONTACT

Uta C. Hoppe, Prof.MD.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Senior Physician, Principal Investigator

Study Record Dates

First Submitted

June 21, 2021

First Posted

June 30, 2021

Study Start

June 9, 2021

Primary Completion

August 8, 2025

Study Completion

September 8, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations