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

Radial Artery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04303923
• Other study ID #: DRAUS
• Status: Completed
• Start date: July 7, 2017
• Est. completion date: February 29, 2020

Study information

• Verified date: March 2020
• Source: Wonju Severance Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1162
• Est. completion date: February 29, 2020
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients planned to perform transthoracic echocardiography with arterial ultrasonography

Exclusion Criteria:

• Age under 20-year

• Poor image quality

• repeated measurement

Related Conditions & MeSH terms

• Radial Artery

Intervention

Procedure:
• Ultrasonography
The diameters of both the radial artery and the distal radial artery were measured by ultrasonography.

Locations

Country	Name	City	State
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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