Coronary Artery DiseaseRAUSTNCT01605292
Radial Artery Access With Ultrasound Trial
A study testing Ultrasound guidance and Palpation in people with Coronary Artery Disease, run by University of California, Irvine at 6 sites in United States.
Trial summary
Radial artery access for cardiac catheterization can require multiple attempts. Multiple attempts increase the time required, patient discomfort, and the risk of arterial spasm. Ultrasound guidance has been shown in other studies to reduce the number of attempts and complications in central venous and femoral artery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ultrasound guidance and Palpation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 698 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients presenting for cardiac or peripheral catheterization with planned radial approach.
- Barbeau's or Allen's test indicating at least some degree of collateral circulation in palmar vessels
- Functional ultrasound equipment with ultrasound trained attending operator
Who cannot join
- Inability to provide informed consent
- Femoral access
- Emergency procedure (Shock, STEMI)
- End-stage renal disease on hemodialysis
- Previous ipsilateral puncture within 1 week
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Jamaica Hospital
Jamaica, New York, 11418
Long Beach VA Medical Center
Long Beach, California, 90822
Baptist Hospital of Miami
Miami, Florida, 33176
Lenox Hill Hospital
New York, New York, 10075
Oklahoma VA Medical Center
Oklahoma City, Oklahoma, 73104
University of California Irvine Medical Center
Orange, California, 92868
About this study
Radial artery access for cardiac catheterization can require multiple attempts. Multiple attempts increase the time required, patient discomfort, and the risk of arterial spasm. Ultrasound guidance has been shown in other studies to reduce the number of attempts and complications in central venous and femoral artery access. This study will test if the addition of ultrasound guidance reduces the number of attempts and time required to access the radial artery.
- Conditions
- Coronary Artery Disease
- Being tested
- Ultrasound guidance, Palpation
- Keywords
- Transradial catheterization, Ultrasound, Radial artery
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guidanceProcedure or surgery
Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.
PalpationProcedure or surgery
Manual palpation for localizing radial artery for inserting needle.
| Study group | Role | What they receive |
|---|---|---|
| Palpation | Active comparator | Manual palpation of radial pulse, as sole guide to needle cannulation. Receives: Procedure: Palpation |
| Ultrasound | Experimental | Real-time ultrasound guidance to facilitate needle cannulation of artery. Receives: Procedure: Ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Attempts
Number of passes of the needle required to access the artery during the cardiac catheterization procedure. This is only assessed at the time of the procedure, i.e. during the first 30 minutes. This is to be reported as both total number of attempts and as a first pass success rate.
Measured: Immediately during procedure. (up to 30 minutes)
Secondary outcomes (2)
Time to Sheath Insertion (Seconds)
Time from initiation of vascular access attempts to successful aspiration or flushing of the sheath. Time for lidocaine administration, palpation of pulse, or imaging is excluded.
Measured: Immediately during procedure (within 30 minutes)
First-pass Success Rate
Proportion of procedures achieving access on the first attempt
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 698 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Lenox Hill Hospital, Jamaica Hospital Medical Center, Oklahoma City VA Medical Center
- Responsible party
- Principal investigator, Arnold Seto, University of California, Irvine
- Investigators
- Arnold H Seto, MD, MPA, Principal investigator, University of California, Irvine and Long Beach VA Medical CenterZoran Lasic, MD, Principal investigator, Lenox Hill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605292
- Sponsor's protocol ID
- 2011-8432
- Acronym
- RAUST
- Status last verified
- Feb 2015
- First submitted
- 26 Jan 2012
- Last updated
- 26 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Seto AH, Roberts JS, Abu-Fadel MS, Czak SJ, Latif F, Jain SP, Raza JA, Mangla A, Panagopoulos G, Patel PM, Kern MJ, Lasic Z. Real-time ultrasound guidance facilitates transradial access: RAUST (Radial Artery access with Ultrasound Trial). JACC Cardiovasc Interv. 2015 Feb;8(2):283-291. doi: 10.1016/j.jcin.2014.05.036. Epub 2015 Jan 14.
PubMed 25596790Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
PubMed 34637140
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Artery Access With Ultrasound Trial
- ClinicalTrials.gov ID
- NCT01605292
- Acronym / sponsor ID
- RAUST / 2011-8432
- Conditions
- Coronary Artery Disease
- Keywords
- Transradial catheterization, Ultrasound, Radial artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Lenox Hill Hospital, Jamaica Hospital Medical Center, Oklahoma City VA Medical Center
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 24 May 2012 (estimated)
- Results
- Posted 26 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radial artery access for cardiac catheterization can require multiple attempts. Multiple attempts increase the time required, patient discomfort, and the risk of arterial spasm. Ultrasound guidance has been shown in other studies to reduce the number of attempts and complications in central venous and femoral artery access. This study will test if the addition of ultrasound guidance reduces the number of attempts and time required to access the radial artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palpation | Active comparator | Procedure: PalpationManual palpation of radial pulse, as sole guide to needle cannulation. |
| Ultrasound | Experimental | Procedure: Ultrasound guidanceReal-time ultrasound guidance to facilitate needle cannulation of artery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients presenting for cardiac or peripheral catheterization with planned radial approach.
- Barbeau's or Allen's test indicating at least some degree of collateral circulation in palmar vessels
- Functional ultrasound equipment with ultrasound trained attending operator
Key exclusion criteria (5 listed)
- Inability to provide informed consent
- Femoral access
- Emergency procedure (Shock, STEMI)
- End-stage renal disease on hemodialysis
- Previous ipsilateral puncture within 1 week
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 |
|---|---|---|
| Ultrasound guidanceReal time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted. | Procedure or surgery | Ultrasound |
| PalpationManual palpation for localizing radial artery for inserting needle. | Procedure or surgery | Palpation |
Primary outcome
Number of Attempts
Time frame: Immediately during procedure. (up to 30 minutes)
Number of passes of the needle required to access the artery during the cardiac catheterization procedure. This is only assessed at the time of the procedure, i.e. during the first 30 minutes. This is to be reported as both total number of attempts and as a first pass success rate.
2 secondary outcomes
Time to Sheath Insertion (Seconds)
Time frame: Immediately during procedure (within 30 minutes)
First-pass Success Rate
Time frame: Immediate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25596790Seto AH, Roberts JS, Abu-Fadel MS, Czak SJ, Latif F, Jain SP, Raza JA, Mangla A, Panagopoulos G, Patel PM, Kern MJ, Lasic Z. Real-time ultrasound guidance facilitates transradial access: RAUST (Radial Artery access with Ultrasound Trial). JACC Cardiovasc Interv. 2015 Feb;8(2):283-291. doi: 10.1016/j.jcin.2014.05.036. Epub 2015 Jan 14.
- Derived from this study: PubMed 34637140Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
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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.
Arnold H Seto, MD, MPA principal investigator
University of California, Irvine and Long Beach VA Medical Center
Zoran Lasic, MD principal investigator
Lenox Hill Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guidance and Palpation in people with Coronary Artery Disease, run by University of California, Irvine at 6 sites in United States.
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 3 inclusion and 5 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 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Yes. Results are posted in the registry (first posted 26 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Attempts (time frame: Immediately during procedure. (up to 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01605292, which also lists 2 linked publications.
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 26 Feb 2015.