Clinical trial NCT01990924: Low Rate Fluoroscopy to Reduce Radiation Dose During Coronary Angiography and Intervention
Official title: Low Rate Fluoroscopy at Reducing Operator and Patient Radiation Dose During Transradial Coronary Diagnostic Angiography and Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Angina
Unstable Angina
Acute Coronary Syndrome
Keywords: fluoroscopy
radiation
transradial
diagnostic
angiography
cardiac
coronary
angioplasty
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Radiation Exposure
timeFrame: During Cardiac Catheterization
measure: Radiation Exposure
timeFrame: During Cardiac Catheterization
measure: Radiation Exposure
timeFrame: During Cardiac Catheterization
Secondary outcomes:
measure: Procedural Characteristics
timeFrame: During Cardiac Catheterization
measure: Procedural Characteristics
timeFrame: During Cardiac Catheterization
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: IUCPQ - Laval Hospital
Study officials:
affiliation: International Chair on Interventional Cardiology and Transradial Approach
name: Olivier F Bertrand, MD PhD
role: STUDY_CHAIR
References:
citation: 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.