NCT04303923

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,162

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

9 months

First QC Date

March 9, 2020

Last Update Submit

March 10, 2020

Conditions

Keywords

anatomical snuffboxdistal radial arteryradial artery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The diameter of radial artery

    Through ultrasonographic evaluation (within 1 hour)

  • Arterial diameter index

    Through ultrasonographic evaluation (within 1 hour)

  • Proportion of small distal radial artery

    Through ultrasonographic evaluation (within 1 hour)

  • Predictor for small distal radial artery

    Through ultrasonographic evaluation (within 1 hour)

Study Arms (2)

Male group

Male patients who performed transthoracic echocardiography with arterial ultrasonography

Procedure: Ultrasonography

Female group

Female patients who performed transthoracic echocardiography with arterial ultrasonography

Procedure: Ultrasonography

Interventions

The diameters of both the radial artery and the distal radial artery were measured by ultrasonography.

Female groupMale group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients planned to perform transthoracic echocardiography with arterial ultrasonography

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Jun-Won Lee, MD, PhD

    Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 11, 2020

Study Start

July 7, 2017

Primary Completion

April 13, 2018

Study Completion

February 29, 2020

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations