Radial ArteryNCT04303923
Reference Diameter and Characteristics of Distal Radial Artery by Ultrasonographic Assessement in Korean Patients
An observational study of Radial Artery, run by Wonju Severance Christian Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radial Artery
- What is being tested?
- Ultrasonography
- Type of treatment
- Surgery or procedure
- How many people
- 1,162 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jul 2017to 29 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients planned to perform transthoracic echocardiography with arterial ultrasonography were consecutively enrolled in a single center.
Who may be able to join
- Patients planned to perform transthoracic echocardiography with arterial ultrasonography
Who cannot join
- Age under 20-year
- Poor image quality
- repeated measurement
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
About this study
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.
Read the 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)
- Conditions
- Radial Artery
- Being tested
- Ultrasonography
- Keywords
- anatomical snuffbox, distal radial artery, radial artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyProcedure or surgery
The diameters of both the radial artery and the distal radial artery were measured by ultrasonography.
| Study group | Role | What they receive |
|---|---|---|
| Male group | Male patients who performed transthoracic echocardiography with arterial ultrasonography Receives: Procedure: Ultrasonography | |
| Female group | Female patients who performed transthoracic echocardiography with arterial ultrasonography Receives: Procedure: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diameter of distal radial artery
Mean diameter of distal radial artery on both left and right hand
Measured: Through ultrasonographic evaluation (within 1 hour)
Secondary outcomes (4)
The diameter of radial artery
Mean diameter of radial artery on both left and right hand
Measured: Through ultrasonographic evaluation (within 1 hour)
Arterial diameter index
Diameter of measure artery divided by body surface area
Measured: Through ultrasonographic evaluation (within 1 hour)
Proportion of small distal radial artery
Proportion of small distal radial artery (<2.3mm)
Measured: Through ultrasonographic evaluation (within 1 hour)
Predictor for small distal radial artery
Clinical predictor associated with small distal radial artery
Measured: Through ultrasonographic evaluation (within 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start7 Jul 2017
- Primary completion13 Apr 2018
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Won Lee, Wonju Severance Christian Hospital
- Investigators
- Jun-Won Lee, MD, PhD, Principal investigator, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303923
- Sponsor's protocol ID
- DRAUS
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Diameter and Characteristics of Distal Radial Artery by Ultrasonographic Assessement in Korean Patients
- ClinicalTrials.gov ID
- NCT04303923
- Acronym / sponsor ID
- DRAUS
- Conditions
- Radial Artery
- Keywords
- anatomical snuffbox, distal radial artery, radial artery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,162 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male group | – | Procedure: UltrasonographyMale patients who performed transthoracic echocardiography with arterial ultrasonography |
| Female group | – | Procedure: UltrasonographyFemale patients who performed transthoracic echocardiography with arterial ultrasonography |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planned to perform transthoracic echocardiography with arterial ultrasonography were consecutively enrolled in a single center.
Key inclusion criteria (1 listed)
- Patients planned to perform transthoracic echocardiography with arterial ultrasonography
Key exclusion criteria (3 listed)
- Age under 20-year
- Poor image quality
- repeated measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyThe diameters of both the radial artery and the distal radial artery were measured by ultrasonography. | Procedure or surgery | Female group, Male group |
Primary outcome
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
4 secondary outcomes
The diameter of radial artery
Time frame: Through ultrasonographic evaluation (within 1 hour)
Arterial diameter index
Time frame: Through ultrasonographic evaluation (within 1 hour)
Proportion of small distal radial artery
Time frame: Through ultrasonographic evaluation (within 1 hour)
Predictor for small distal radial artery
Time frame: Through ultrasonographic evaluation (within 1 hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun-Won Lee, MD, PhD principal investigator
Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radial Artery, run by Wonju Severance Christian Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diameter of distal radial artery (time frame: Through ultrasonographic evaluation (within 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.