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

Low Rate Fluoroscopy at Reducing Operator and Patient Radiation Dose During Transradial Coronary Diagnostic Angiography and Interventions

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01990924

Enrollment

385

Registered

2013-11-25

Start date

2012-10-31

Completion date

2013-08-31

Last updated

2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Stable Angina, Unstable Angina

Keywords

fluoroscopy, radiation, transradial, diagnostic, angiography, cardiac, coronary, angioplasty

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.

Detailed description

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.

Interventions

RADIATION15 FPS

X-ray pictures

RADIATION7.5 FPS

X-ray pictures

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Radiation Exposure	During Cardiac Catheterization	Operator radiation dose (measured with dosimeter attached to the left side of thyroid shield, in µSv)

Secondary

Measure	Time frame	Description
Procedural Characteristics	During Cardiac Catheterization	Procedural duration

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026