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

NCT ID: NCT04285944

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-05-31

Brief Summary

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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®.

Detailed Description

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Conditions

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Radiation Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study

Group Type ACTIVE_COMPARATOR

Mavig X-ray Protective Drapes

Intervention Type OTHER

Mavig X-ray Protective Drapes®

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mavig X-ray Protective Drapes

Mavig X-ray Protective Drapes®

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1\. The procedure is an emergency and/or the patient is unstable. -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Prof Dr Walter Desmet

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keir Mccutcheon

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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Department of Cardiovascular Disease, University Hospitals Leuven

Leuven, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Sabine Van Roey

Role: CONTACT

003216342465 ext. +32468312267

Keir Mccutcheon

Role: CONTACT

+32468312267 ext. +32468312267

Facility Contacts

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Sabine Van Roey

Role: primary

003216342465

Sabine Van Roey

Role: primary

+32 16 34 24 66

References

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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.

Reference Type DERIVED
PMID: 34987314 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33092401 (View on PubMed)

Other Identifiers

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S62469

Identifier Type: -

Identifier Source: org_study_id

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