NCT01990924

Brief Summary

Objectives: To determine the efficacy of low rate fluoroscopy at 7.5 frames per second (FPS) vs. conventional 15 FPS for reduction of operator and patient radiation dose during diagnostic coronary angiography and percutaneous coronary intervention via the transradial approach. Background: Transradial approach for cardiac catheterization is potentially associated with increased radiation exposure. Low rate fluoroscopy has potential to reduce radiation exposure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

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

October 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

10 months

First QC Date

November 7, 2013

Last Update Submit

November 18, 2013

Conditions

Stable AnginaUnstable AnginaAcute Coronary Syndrome

Keywords

fluoroscopyradiationtransradialdiagnosticangiographycardiaccoronaryangioplasty

Outcome Measures

Primary Outcomes (3)

  • Radiation Exposure

    Operator radiation dose (measured with dosimeter attached to the left side of thyroid shield, in µSv)

    During Cardiac Catheterization

  • Radiation Exposure

    Patient radiation dose (expressed as dose-area product \[DAP\] in μGy.m2)

    During Cardiac Catheterization

  • Radiation Exposure

    Fluoroscopy time

    During Cardiac Catheterization

Secondary Outcomes (2)

  • Procedural Characteristics

    During Cardiac Catheterization

  • Procedural Characteristics

    During Cardiac Catheterization

Study Arms (2)

7.5 FPS

EXPERIMENTAL

Low rate fluoroscopy at 7.5 frames per second (FPS)

Radiation: 7.5 FPS

15 FPS

ACTIVE COMPARATOR

Conventional rate fluoroscopy at 15 FPS

Radiation: 15 FPS

Interventions

15 FPSRADIATION

X-ray pictures

Also known as: Standard practice, conventional 15 frames per second (FPS)
15 FPS
7.5 FPSRADIATION

X-ray pictures

Also known as: Low rate fluoroscopy at 7.5 FPS
7.5 FPS

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing elective, urgent or emergent cardiac catheterization procedures with or without ad hoc PCI, via transradial approach are eligible.

You may not qualify if:

  • \) non-transradial access and 2) participation in research project(s) requiring higher ie 30 FPS cine angiography.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IUCPQ - Laval Hospital

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

  • Abdelaal E, Plourde G, MacHaalany J, Arsenault J, Rimac G, Dery JP, Barbeau G, Larose E, De Larochelliere R, Nguyen CM, Allende R, Ribeiro H, Costerousse O, Mongrain R, Bertrand OF; Interventional Cardiologists at Quebec Heart-Lung Institute. Effectiveness of low rate fluoroscopy at reducing operator and patient radiation dose during transradial coronary angiography and interventions. JACC Cardiovasc Interv. 2014 May;7(5):567-74. doi: 10.1016/j.jcin.2014.02.005. Epub 2014 Apr 16.

    PMID: 24746649DERIVED

MeSH Terms

Conditions

Angina, StableAngina, UnstableAcute Coronary SyndromeDisease

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Olivier F Bertrand, MD PhD

    International Chair on Interventional Cardiology and Transradial Approach

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 25, 2013

Study Start

October 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

CA(1)