Reference Diameter and Characteristics of Distal Radial Artery by Ultrasonographic Assessement in Korean Patients

March 10, 2020 updated by: Jun-Won Lee, Wonju Severance Christian Hospital
Radial access is recommended as the standard approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI) based on the evidence in which RA reduced mortality and bleeding events compared with femoral access. Recently, the use of distal radial artery (DRA) is rapidly increasing in accordance with the publication of several studies that have shown easy hemostasis, reduced bleeding complications and low arterial occlusion rate via distal radial approach. However, the diameter of DRA is relatively smaller than radial artery (RA) which can limit the widespread use of this access route. Regarding the size discrepancy, there is a lack of evidence to guide which patients are acceptable or not for CAG and PCI. Therefore, the main purpose of this study was to provide the reference diameter of DRA using ultrasonography in Korean patients. The clinical predictors for small DRA also were evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Radial access is recommended as the standard approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI) based on the evidence in which RA reduced mortality and bleeding events compared with femoral access. Recently, the use of distal radial artery (DRA) is rapidly increasing in accordance with the publication of several studies that have shown easy hemostasis, reduced bleeding complications and low arterial occlusion rate via distal radial approach. However, the diameter of DRA is relatively smaller than radial artery (RA) which can limit the widespread use of this access route. Regarding the size discrepancy, there is a lack of evidence to guide which patients are acceptable or not for CAG and PCI. Therefore, the main purpose of this study was to provide the reference diameter of DRA using ultrasonography in Korean patients. The clinical predictors for small DRA also were evaluated.

Assessment of arterial diameter by ultasonography Patients were lying on the bed with relaxation in an quiet room. The outer diameters of both DRA and RA were assessed by a perpendicular angle using a linear ultrasound probe (3-4-10.8 MHz) and the average values were recorded. The diameter of RA was measured from 2-3 cm above wrist crease. Anatomical landmark for the measurement of DRA was the bony surface area just distal space from extensor pollicis longus tendon in which the DRA was best palpable then runs down between the first metacarpal and second metacarpal bone (just out of anatomical snuffbox area)

Study Type

Observational

Enrollment (Actual)

1162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gangwon-do
      • Wonju, Gangwon-do, Korea, Republic of, 26426
        • Wonju Severance Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients planned to perform transthoracic echocardiography with arterial ultrasonography were consecutively enrolled in a single center.

Description

Inclusion Criteria:

  • Patients planned to perform transthoracic echocardiography with arterial ultrasonography

Exclusion Criteria:

  • Age under 20-year
  • Poor image quality
  • repeated measurement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Male group
Male patients who performed transthoracic echocardiography with arterial ultrasonography
The diameters of both the radial artery and the distal radial artery were measured by ultrasonography.
Female group
Female patients who performed transthoracic echocardiography with arterial ultrasonography
The diameters of both the radial artery and the distal radial artery were measured by ultrasonography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diameter of distal radial artery
Time Frame: Through ultrasonographic evaluation (within 1 hour)
Mean diameter of distal radial artery on both left and right hand
Through ultrasonographic evaluation (within 1 hour)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diameter of radial artery
Time Frame: Through ultrasonographic evaluation (within 1 hour)
Mean diameter of radial artery on both left and right hand
Through ultrasonographic evaluation (within 1 hour)
Arterial diameter index
Time Frame: Through ultrasonographic evaluation (within 1 hour)
Diameter of measure artery divided by body surface area
Through ultrasonographic evaluation (within 1 hour)
Proportion of small distal radial artery
Time Frame: Through ultrasonographic evaluation (within 1 hour)
Proportion of small distal radial artery (<2.3mm)
Through ultrasonographic evaluation (within 1 hour)
Predictor for small distal radial artery
Time Frame: Through ultrasonographic evaluation (within 1 hour)
Clinical predictor associated with small distal radial artery
Through ultrasonographic evaluation (within 1 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jun-Won Lee, MD, PhD, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 7, 2017

Primary Completion (ACTUAL)

April 13, 2018

Study Completion (ACTUAL)

February 29, 2020

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (ACTUAL)

March 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • DRAUS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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