NCT01510353

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
505

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 4, 2014

Status Verified

July 1, 2014

Enrollment Period

2.3 years

First QC Date

January 9, 2012

Last Update Submit

July 2, 2014

Conditions

Radiation MonitoringRadiation Protection

Outcome Measures

Primary Outcomes (1)

  • Radiation exposure of the operator

    Radiation exposure of the operator (measured in mrem by the real time monitoring device)

    radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour

Secondary Outcomes (1)

  • Radiation exposure of the patient

    radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour

Study Arms (2)

Use of a radiation monitoring device

EXPERIMENTAL

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

Device: Radiation monitoring device

No use of radiation monitoring device

NO INTERVENTION

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

Interventions

Radiation monitoring deviceDEVICE

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

Use of a radiation monitoring device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing clinically-indicated cardiac catheterization

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

Related Publications (1)

  • 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.

    PMID: 25423958DERIVED

Study Officials

  • Emmanouil S. Brilakis, MD, PhD

    North Texas Veterans Healthcare System

    STUDY CHAIR

  • Subhash Banerjee, MD

    North Texas Veterans Healthcare System

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cardiac Catheterization Laboratories

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 16, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 4, 2014

Record last verified: 2014-07

Locations

US(1)