Radiation Exposure
Conditions
Keywords
DOSE-PCI
Brief summary
This study aims to compare the operator's radiation exposure between left distal radial access (LDRA) and right transradial access (RTRA) in patients undergoing percutaneous coronary intervention (PCI).
Interventions
Radial Artery Puncture Method for Coronary Intervention
Sponsors
Yonsei University
Yonsei University Yongin Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Conventional Right Radial versus Left Distal Radial Approach for Percutaneous Coronary Interventions
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged 19 years or older 2. Patients scheduled for PCI
Exclusion criteria
1. Non-palpable left distal radial artery pulse 2. Non-palpable right radial artery pulse 3. Presence of arteriovenous fistula 4. Need for femoral access as determined by the investigator 5. Refusal to provide informed consent 6. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative operator radiation exposure during PCI (µSv) with a set of 3 radiation detection dosimeters on left wrist, left head, and left chest | Through procedure completion, up to 24 hours | To compare the cumulative radiation dose (µSv) received by the operator between the left distal radial artery approach and the right radial artery approach during PCI. Radiation exposure is measured using a set of three radiation detection dosimeters placed on the operator's left wrist, left head, and left chest. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| crossover rate (%) | Through procedure completion, up to 24 hours | The percentage of participants who required a change in the initial arterial access site to a different site to successfully complete the PCI procedure. |
| Fluoroscopy time (min) | Through procedure completion, up to 24 hours | Total duration of exposure to fluoroscopy during the PCI procedure, measured in minutes. |
| Procedure time (min) | Through procedure completion, up to 24 hours | Total time from the first skin incision or needle puncture to the removal of the last catheter/sheath, measured in minutes. |
| volume of contrast medium used (mL) | Through procedure completion, up to 24 hours | Total volume of radiopaque contrast media administered to the participant during the procedure, measured in milliliters (mL). |
Countries
Japan, South Korea
Contacts
CONTACTYongcheol Kim, MD, PhD
PRINCIPAL_INVESTIGATORYongcheol Kim, MD, PhD
Severance Hospital
Outcome results
None listed