Determinants of Operator Radiation Exposure During Percutaneous Coronary Procedures According to Vascular Access: the RADIANT II Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,000
- Primary Endpoint
- mean operator radiation dose
Study Overview
Brief Summary
Trial's objective is to evaluate:
i. if there's any difference between the operator radiation exposure during diagnostic coronary angiography and/or percutaneous coronary intervention (PCI) performed through right-side artery accesses (wrist transradial access and distal transradial access) versus left distal radial artery access ii. the relationship between operator radiation exposure and other clinical and procedural characteristics, to assess independent predictors of operator radiation exposure. Design of the study: prospective multicenter observational cohort registry (OCR).
The purpose of this OCR is to assess the radiation exposure of interventional cardiologist during a diagnostic coronary angiography and/or PCI according to vascular access used (see above). Coronary angiography and PCI will be performed according to usual practice
Detailed Description
Patient population:
During 6 months, at least 1000 consecutive patients (age > 18 years) referred for diagnostic coronary angiography in up to 10 centers in Italy involving a minimum of 4 operators will be enrolled. To be qualified as expert, operators should have performed at least 250 transradial procedure/year in the previous 3 years and have performed at least 20 right and left distal radial procedures.
Demographic and medical history data of patients including age, sex, history of diabetes mellitus, hypertension, height and weight will be collected. Height and weight of operators will be also recorded. Type of angiographic system will be recorded. Procedural data as contrast medium amount, subclavian tortuosity, numbers of diagnostic and guiding catheters and numbers of cine-angiographic acquisitions (frames) will be also recorded.
Subclavian tortuosity will be classified as:
- Grade 1: tortuosity or calcification of the subclavian artery that can be crossed by a standard 0.035" nonhydrophilic wire facilitated with deep inspiration
- Grade 2: tortuosity or calcification of the subclavian artery that can be crossed with a 0.0035" hydrophilic wire and a standard diagnostic catheter
- Grade 3: tortuosity or calcification of the subclavian artery or congenital anomalies that require a 0.035" stiff wire and a standard catheter
- Grade 4: severe tortuosity and/or calcification of the subclavian artery or congenital anomalies preventing the catheter or guide to reach the aortic valve plane or engage the coronary ostia with a stiff wire Subclavian tortuosity > grade 2 will be considered as significative. Type of catheters and the number of views for angiography and PCI will be left to the discretion of the operator. Lead shields placed under the catheterization table, as well as ceiling mounted lead shields, will be used in every procedure. Procedural success is defined as completion of the procedure through the intended arterial access. Crossover, if needed, is permitted to femoral access or to contralateral arm or approach.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients admitted for coronary diagnostic angiography in the setting of valvular disease, stable angina, suspected coronary artery disease, acute coronary syndrome with or without ST segment elevation myocardial infarction who underwent diagnostic coronary angiography through right radial, right distal radial and left distal radial access.
- •patients admitted for ad-Hoc PCI through any radial access
- •patients age > 18 years-old
- •signed informed consent
Exclusion Criteria
- •hemodynamic instability
Outcomes
Primary Outcomes
mean operator radiation dose
Time Frame: 1 year
mean operator radiation dose at the torax (expressed in µSy)
Secondary Outcomes
- mean fluoroscopy time(1 year)
- patient radiation exposure(from beginning to end of coronary procedure)
- mean DAP-normalized operator dose(1 year)
- mean operator effective dose(1 year)