EffectivenesS of Additional X-ray PRotection dEviceS in Reducing Scattered Radiation in Radial interventiOn

NCT ID: NCT03634657

Last Updated: 2020-10-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-16

Study Completion Date

2020-10-01

Brief Summary

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This study evaluates the radiation exposure of scattered radiation for the interventionalist during coronary angiography using different X-ray protection materials, namely, an X-ray Screen without additional X-ray protection, an X-ray Screen with additional protective strips and an X-ray Screen with additional protective strips AND protective patient cut-outs.

Detailed Description

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Conditions

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Exposure of Member of Staff to Medical Diagnostic X-Ray

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Plain X-ray protection shield

Group Type ACTIVE_COMPARATOR

Plain X-ray protection shield

Intervention Type RADIATION

Coronary angiography with mere X-ray protection shield

Protection shield & X-ray protective strips

Group Type EXPERIMENTAL

Protection shield & X-ray protective strips

Intervention Type RADIATION

Coronary angiography with X-ray protection shield \& X-ray protective strips

Protection shield & protective strips & patient cut-outs

Group Type EXPERIMENTAL

Protection shield & protective strips & patient cut-outs

Intervention Type RADIATION

Coronary angiography with X-ray protection shield \& X-ray protective strips \& X-ray protection patient cut-outs

Interventions

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Plain X-ray protection shield

Coronary angiography with mere X-ray protection shield

Intervention Type RADIATION

Protection shield & X-ray protective strips

Coronary angiography with X-ray protection shield \& X-ray protective strips

Intervention Type RADIATION

Protection shield & protective strips & patient cut-outs

Coronary angiography with X-ray protection shield \& X-ray protective strips \& X-ray protection patient cut-outs

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* indication for coronary angiography

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tommaso Gori

OTHER

Sponsor Role lead

Responsible Party

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Tommaso Gori

Director, Cardiac Catheterization Laboratory ; Director, Study center of Center for Cardiology, university hospital Mainz

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University Medical Center Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

References

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Anadol R, Brandt M, Merz N, Knorr M, Ahoopai M, Geyer M, Krompiec D, Wenzel P, Munzel T, Gori T. Effectiveness of additional X-ray protection devices in reducing scattered radiation in radial intervention: the ESPRESSO randomised trial. EuroIntervention. 2020 Oct 23;16(8):663-671. doi: 10.4244/EIJ-D-19-00945.

Reference Type DERIVED
PMID: 32338611 (View on PubMed)

Anadol R, Brandt M, Merz N, Knorr M, Ahoopai M, Geyer M, Krompiec D, Wenzel P, Munzel T, Gori T. Effectiveness of additional X-ray protection devices in reducing Scattered radiation in radial interventions: protocol of the ESPRESSO randomised trial. BMJ Open. 2019 Jul 3;9(7):e029509. doi: 10.1136/bmjopen-2019-029509.

Reference Type DERIVED
PMID: 31272982 (View on PubMed)

Other Identifiers

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ESPRESSO

Identifier Type: -

Identifier Source: org_study_id

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