Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®.

NCT04285944 | Unknown

• 1 other identifier: S62469
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

Interventional cardiologists are exposed to significant doses of scatter radiation during cardiac catheterization and percutaneous coronary intervention. Traditional methods of reducing the radiation dose for operators in the cardiac catheterization laboratory include limiting the use of radiation, radiation protection aprons and shields, and the use of lead eye glasses. Despite these measures several parts of the operators body, including the head and neck, are poorly screened from scatter radiation. Radiation protection drapes have been developed for use in cardiac catheterization but no randomized controlled study has yet been performed with the commercially available Mavig X-ray Protective Drapes®. The aim of this study is to evaluate operator radiation protection using Mavig X-ray Protective Drapes®.

Conditions

Radiation Exposure

Outcome Measures

Primary Outcomes (1)

• Operator radiation dose

  Gray

  Immediate

Study Arms (2)

Study

ACTIVE COMPARATOR

Other: Mavig X-ray Protective Drapes

Control

NO INTERVENTION

Interventions

Mavig X-ray Protective Drapes OTHER

Mavig X-ray Protective Drapes®

Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing the procedure is older than 18 years and is planned for a coronary angiogram, cardiac catheterization and/or percutaneous coronary intervention.
• The coronary angiogram/cardiac catheterization/PCI procedure is elective.
• The patient undergoing the procedure is male, or if female, has no childbearing potential or is not pregnant.

You may not qualify if:

• \. The procedure is an emergency and/or the patient is unstable. -

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (2)

Department of Cardiovascular Disease, University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

Related Publications (2)

• McCutcheon K, Vanhaverbeke M, Dabin J, Pauwels R, Schoonjans W, Desmet W, Bennett J. Efficacy of MAVIG X-Ray Protective Drapes in Reducing CTO Operator Radiation. J Interv Cardiol. 2021 Dec 14;2021:3146104. doi: 10.1155/2021/3146104. eCollection 2021.

  PMID: 34987314 DERIVED

• McCutcheon K, Vanhaverbeke M, Pauwels R, Dabin J, Schoonjans W, Bennett J, Adriaenssens T, Dubois C, Sinnaeve P, Desmet W. Efficacy of MAVIG X-Ray Protective Drapes in Reducing Operator Radiation Dose in the Cardiac Catheterization Laboratory: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2020 Nov;13(11):e009627. doi: 10.1161/CIRCINTERVENTIONS.120.009627. Epub 2020 Oct 23.

  PMID: 33092401 DERIVED

Study Officials

• Keir Mccutcheon

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine Van Roey

CONTACT

003216342465; sabine.vanroey@uzleuven.be

Keir Mccutcheon

CONTACT

+32468312267; keir.mccutcheon@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: October 1, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)