Clinical trial NCT04023838: Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach
Official title: Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach: The DOSE Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiation Exposure
Vascular Access Complication
Radial Artery Injury
Keywords: Radiation
Snuffbox approach
Radial approach
Vascular access
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized either conventional right radial approach or left distal radial approach.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiation dose of the operator (µSv)
timeFrame: Through procedure completion, up to 6 hours
Secondary outcomes:
measure: Fluoroscopy time for coronary angiography (second)
timeFrame: Through procedure completion, up to 6 hours
measure: Dose-area product (mGy*cm2)
timeFrame: Through procedure completion, up to 6 hours
measure: Success rate of radial puncture (%)
timeFrame: Through procedure completion, up to 6 hours
measure: Cannulation time (second)
timeFrame: Through procedure completion, up to 6 hours
measure: Hemostasis duration (minute)
timeFrame: During hospitalization, up to 1 month
measure: Puncture site complication after hemostasis
timeFrame: During hospitalization, up to 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Department of Cardiology, Chonnam National University Hospital
name: Yongcheol Kim, MD
role: STUDY_DIRECTOR
References: