Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization

NCT ID: NCT01510353

Last Updated: 2014-07-04

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-05-31

Brief Summary

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The purpose of this study is to examine the impact of using a real time radiation exposure monitoring device on the patient and operator radiation exposure during cardiac catheterization. The hypothesis of the study is that use of a real time radiation exposure monitoring device during cardiac catheterization will decrease both patient and operator radiation exposure compared to no use of the monitoring device.

Detailed Description

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Conditions

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Radiation Monitoring Radiation Protection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Use of a radiation monitoring device

Use of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization

Group Type EXPERIMENTAL

Radiation monitoring device

Intervention Type DEVICE

Radiation monitoring device (Bleeper Sv, Vertec Scientific Ltd, Berkshire, UK) that provides real-time auditory feedback on radiation exposure during cardiac catheterization

No use of radiation monitoring device

No use of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Radiation monitoring device

Radiation monitoring device (Bleeper Sv, Vertec Scientific Ltd, Berkshire, UK) that provides real-time auditory feedback on radiation exposure during cardiac catheterization

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing clinically-indicated cardiac catheterization

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Texas Veterans Healthcare System

FED

Sponsor Role lead

Responsible Party

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Emmanouil Brilakis

Director, Cardiac Catheterization Laboratories

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emmanouil S. Brilakis, MD, PhD

Role: STUDY_CHAIR

North Texas Veterans Healthcare System

Subhash Banerjee, MD

Role: STUDY_DIRECTOR

North Texas Veterans Healthcare System

Locations

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VA North Texas Health Care System

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Christopoulos G, Papayannis AC, Alomar M, Kotsia A, Michael TT, Rangan BV, Roesle M, Shorrock D, Makke L, Layne R, Grabarkewitz R, Haagen D, Maragkoudakis S, Mohammad A, Sarode K, Cipher DJ, Chambers CE, Banerjee S, Brilakis ES. Effect of a real-time radiation monitoring device on operator radiation exposure during cardiac catheterization: the radiation reduction during cardiac catheterization using real-time monitoring study. Circ Cardiovasc Interv. 2014 Dec;7(6):744-50. doi: 10.1161/CIRCINTERVENTIONS.114.001974. Epub 2014 Nov 25.

Reference Type DERIVED
PMID: 25423958 (View on PubMed)

Other Identifiers

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11-097

Identifier Type: -

Identifier Source: org_study_id

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