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

NCT04023838 | Unknown

• 1 other identifier: DOSE
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Radiation Exposure; Vascular Access Complication; Radial Artery Injury

Keywords

Radiation; Snuffbox approach; Radial approach; Vascular access

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Cannulation time (second)

  Through procedure completion, up to 6 hours

• Hemostasis duration (minute)

  During hospitalization, up to 1 month

Study Arms (2)

Right conventional radial approach

PLACEBO COMPARATOR

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

Left distal radial approach

ACTIVE COMPARATOR

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

Interventions

artery puncture and coronary angiography PROCEDURE

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).

Left distal radial approach; Right conventional radial approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonnam National University Hospital: lead

Study Officials

• Yongcheol Kim, MD

  Department of Cardiology, Chonnam National University Hospital

  STUDY DIRECTOR

Central Study Contacts

Yongcheol Kim, MD

CONTACT

+82-10-5808-4029; Dr.YongcheolKim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2020
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share