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

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

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

Study Overview

• Status: Unknown
• Conditions: Radiation Exposure; Vascular Access Complication; Radial Artery Injury
• Intervention / Treatment: Procedure: artery puncture and coronary angiography

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yongcheol Kim, MD; Phone Number: +82-10-5808-4029; Email: Dr.YongcheolKim@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Right conventional radial approach; After local anesthesia on right wrist area with lidocaine hydrochloride using a 26 gauge needle, the puncture is performed using a 20 gauge needle with the through-and-through puncture technique or a 21 gauge open needle with anterior wall puncture technique. After the successful puncture, 0.025-inch straight wire or 0.018-inch hair wire are inserted, followed by insertion of the 5Fr. radial sheath (Prelude® Radial; Merit medical, UT, USA or Radifocus® Introducer II or Glidesheath Slender®; Terumo Corporation, Tokyo, Japan).	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).
Active Comparator: Left distal radial approach; After local anesthesia on left anatomical snuffbox area with lidocaine hydrochloride using a 26 gauge needle, the puncture is performed using a 20 gauge needle with the through-and-through puncture technique or a 21 gauge open needle with anterior wall puncture technique. After the successful puncture, 0.025-inch straight wire or 0.018-inch hair wire are inserted, followed by insertion of the 5Fr. radial sheath (Prelude® Radial; Merit medical, UT, USA or Radifocus® Introducer II or Glidesheath Slender®; Terumo Corporation, Tokyo, Japan).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Success rate of radial puncture (%)	Successful introduction of sheath (%)	Through procedure completion, up to 6 hours
Cannulation time (second)	Time from local anesthesia to sheath cannulation (second)	Through procedure completion, up to 6 hours
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
Puncture site complication after hemostasis	Evaluation of puncture-site bleeding complication using EASY criteria	During hospitalization, up to 1 month

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Investigators: Study Director: Yongcheol Kim, MD, Department of Cardiology, Chonnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Radiation; Vascular access; Radial approach; Snuffbox approach
• Other Study ID Numbers: DOSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No