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Low Rate Fluoroscopy to Reduce Radiation Dose During Coronary Angiography and Intervention

NCT ID: NCT01990924

Last Updated: 2013-11-25

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

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Methods: Patients undergoing transradial approach diagnostic angiography ± ad hoc PCI, wil be randomized to fluoroscopy at 7.5 FPS vs. 15 FPS prior to procedure. Both 7.5 and 15 FPS fluoroscopy protocols will be configured with a fixed dose per pulse of 40 nGy. Primary endpoints will be operator radiation dose (measured with dosimeter attached to the left side of thyroid shield in µSv), patient radiation dose (expressed as dose-area product in μGy.m2), and fluoroscopy time.

Conditions

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Stable Angina Unstable Angina Acute Coronary Syndrome

Keywords

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fluoroscopy radiation transradial diagnostic angiography cardiac coronary angioplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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7.5 FPS

Low rate fluoroscopy at 7.5 frames per second (FPS)

Group Type EXPERIMENTAL

7.5 FPS

Intervention Type RADIATION

X-ray pictures

15 FPS

Conventional rate fluoroscopy at 15 FPS

Group Type ACTIVE_COMPARATOR

15 FPS

Intervention Type RADIATION

X-ray pictures

Interventions

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15 FPS

X-ray pictures

Intervention Type RADIATION

7.5 FPS

X-ray pictures

Intervention Type RADIATION

Other Intervention Names

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Standard practice, conventional 15 frames per second (FPS) Low rate fluoroscopy at 7.5 FPS

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 1\) non-transradial access and 2) participation in research project(s) requiring higher ie 30 FPS cine angiography.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Olivier F. Bertrand

Study Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olivier F Bertrand, MD PhD

Role: STUDY_CHAIR

International Chair on Interventional Cardiology and Transradial Approach

Locations

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IUCPQ - Laval Hospital

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 24746649 (View on PubMed)

Other Identifiers

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7.5 vs 15

Identifier Type: OTHER

Identifier Source: secondary_id

7.5 vs 15 Cine

Identifier Type: -

Identifier Source: org_study_id