Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach: The DOSE Trial
Overview
- Phase
- Not Applicable
- Enrollment
- 100
- Primary Endpoint
- Radiation dose of the operator (µSv)
Overview
Brief Summary
Randomized comparison of radiation exposure in coronary angiography between right conventional and left distal radial artery approach
Detailed Description
The left snuffbox approach is expected to be easier to perform because of less severe tortuosity of the clavicle artery. However, clinical validation of the snuffbox approach was not completed compared with the conventional radial approach. Especially, there is no clinical data on the comparison of the radiation dose in both approaches. To date, there have been some studies on the radiation dose between the left and right radial artery and femoral artery puncture site, but no studies have been conducted on the left snuffbox approach.
The purpose of this study was to compare the radiation doses of the two interventional radiologists by randomly assigning coronary angiography to the left snuffbox approach and right conventional radial approach.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who are a palpable right radial artery and left distal radial artery
- •The decision to participate voluntarily in this study and the written consent of the patient
Exclusion Criteria
- •Patients who are not palpable right radial artery and left distal radial artery
- •Patients who have arteriovenous fistula
- •Patients presenting with acute myocardial infarction
- •Patients who need to perform coronary angiography via femoral approach, such as shock state
- •Patients who have atrioventricular block on the electrocardiogram
- •Patients who have a plan to perform Ergonovine provocation test
- •Patients who need percutaneous coronary intervention
- •Patients who are not appropriate for this study
Outcomes
Primary Outcomes
Radiation dose of the operator (µSv)
Time Frame: Through procedure completion, up to 6 hours
Radiation dose (µSv) of the operator's head, hand, and body will be compared between right conventional radial artery approach and left snuffbox approach group.
Secondary Outcomes
- Fluoroscopy time for coronary angiography (second)(Through procedure completion, up to 6 hours)
- Dose-area product (mGy*cm2)(Through procedure completion, up to 6 hours)
- Success rate of radial puncture (%)(Through procedure completion, up to 6 hours)
- Hemostasis duration (minute)(During hospitalization, up to 1 month)
- Cannulation time (second)(Through procedure completion, up to 6 hours)
- Puncture site complication after hemostasis(During hospitalization, up to 1 month)
Investigators
Myung Ho Jeong
Professor
Chonnam National University Hospital