NCT03605030

Brief Summary

The primary objective of this study is to determine if a novel lead-based arm board is effective at reducing radiation dose to the operator during invasive cardiac procedures. Secondary objectives are to measure effect on radiation dose to patient and total fluoroscopy (x-ray) time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

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

May 29, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

July 21, 2018

Last Update Submit

July 21, 2018

Conditions

Patients Undergoing Invasive Cardiac ProceduresRadiation Exposure

Keywords

Cardiac CatheterizationPercutaneous Coronary InterventionRadiationLead Shielding

Outcome Measures

Primary Outcomes (2)

  • Radiation dose (μSv) to the operator at the chest

    Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.

    At procedure completion

  • Radiation dose (μSv) to the operator at the forearm level

    Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.

    At procedure completion

Secondary Outcomes (3)

  • Air kerma

    At procedure completion

  • Dose area product

    At procedure completion

  • Radiation dose to the patient

    At procedure completion

Study Arms (2)

Novel Lead Based Armboard

ACTIVE COMPARATOR
Device: Novel Lead Based Armboard

Standard Armboard

PLACEBO COMPARATOR
Device: Standard Armboard

Interventions

Novel Lead Based ArmboardDEVICE

Novel Lead Based Armboard

Novel Lead Based Armboard
Standard ArmboardDEVICE

Standard Armboard (without lead)

Standard Armboard

Eligibility Criteria

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

You may qualify if:

  • Age \> 18
  • Planned invasive cardiology procedure, cardiac catheterization with or without percutaneous coronary intervention (PCI), or PCI alone.

You may not qualify if:

  • Inability to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

Location

Study Officials

  • Pallav Garg, MBBS, MSc

    London Health Sciences Centre, Western University, London, ON

    PRINCIPAL INVESTIGATOR

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
Assistant Professor

Study Record Dates

First Submitted

July 21, 2018

First Posted

July 30, 2018

Study Start

May 29, 2017

Primary Completion

January 25, 2018

Study Completion

May 30, 2018

Last Updated

July 30, 2018

Record last verified: 2018-07

Locations

CA(1)