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

Study Overview
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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.

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

Conditions
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Stable Angina, Unstable Angina, Acute Coronary Syndrome

Intervention / Treatment
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* Radiation: 15 FPS
* Radiation: 7.5 FPS


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 7.5 FPS<br>Low rate fluoroscopy at 7.5 frames per second (FPS) | Radiation: 7.5 FPS<br>* X-ray pictures<br>* Other names: Low rate fluoroscopy at 7.5 FPS;|
| Active Comparator: 15 FPS<br>Conventional rate fluoroscopy at 15 FPS | Radiation: 15 FPS<br>* X-ray pictures<br>* Other names: Standard practice, conventional 15 frames per second (FPS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Characteristics | Procedural duration | During Cardiac Catheterization | 
| Procedural Characteristics | Total contrast volume used | During Cardiac Catheterization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac, fluoroscopy, radiation, transradial, diagnostic, angiography, coronary, angioplasty