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

Sponsor

Chonnam National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04023838

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Radiation Exposure Vascular Access Complication Radial Artery Injury	Procedure: artery puncture and coronary angiography	N/A

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

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomized either conventional right radial approach or left distal radial approach.Patients will be randomized either conventional right radial approach or left distal radial approach.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Aug 1, 2019

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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).

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

Outcome Measures

Primary Outcome Measures

Radiation dose of the operator (µSv) [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chonnam National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Myung Ho Jeong, Professor, Chonnam National University Hospital

ClinicalTrials.gov Identifier:

NCT04023838

Other Study ID Numbers:

DOSE

First Posted:

Jul 18, 2019

Last Update Posted:

Jul 18, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Myung Ho Jeong, Professor, Chonnam National University Hospital

Study Results

No Results Posted as of Jul 18, 2019