Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach

Radiation Exposure Clinical Trial

— DOSE  

Official title:

Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach: The DOSE Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04023838
• Other study ID #: DOSE
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2019
• Est. completion date: December 2020

Study information

• Verified date: July 2019
• Source: Chonnam National University Hospital
• Contact: Yongcheol Kim, MD
• Phone: +82-10-5808-4029
• Email: Dr.YongcheolKim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized comparison of radiation exposure in coronary angiography between right conventional and left distal radial artery approach

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Radial Artery Injury
• Radiation Exposure
• Vascular Access Complication

Intervention

Procedure:
• artery puncture and coronary angiography
We will perform coronary angiography through a Judkins 5 French diagnostic catheter and will take a basic view. At the end of the examination, the radial sheath is removed and the right conventional radial approach is performed for about 4 hours and the left snuffbox approach for about 2 hours using the compressive bandage method. The hemostatic device will use ez ClotRadial® (SOYEON medical Co., Ltd., Wonju, Korea).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation dose of the operator (µSv)	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.	Through procedure completion, up to 6 hours
Secondary	Fluoroscopy time for coronary angiography (second)	Fluoroscopy time (second) will be compared between two groups during coronary angiography.	Through procedure completion, up to 6 hours
Secondary	Dose-area product (mGy*cm2)	Dose-area product (DAP) (mGy*cm2) will be compared between two groups during coronary angiography.	Through procedure completion, up to 6 hours
Secondary	Success rate of radial puncture (%)	Successful introduction of sheath (%)	Through procedure completion, up to 6 hours
Secondary	Cannulation time (second)	Time from local anesthesia to sheath cannulation (second)	Through procedure completion, up to 6 hours
Secondary	Hemostasis duration (minute)	Hemostasis (minute) is obtained by compressive bandage with ez ClotRadial® (SOYEON medical Co., Ltd., Wonju, Korea)	During hospitalization, up to 1 month
Secondary	Puncture site complication after hemostasis	Evaluation of puncture-site bleeding complication using EASY criteria	During hospitalization, up to 1 month