Radial Artery OcclusionRATATOUILLENCT03789279
Observational Study of Hand Function After Distal Transradial Access for Angiography
An observational study of Radial Artery Occlusion and Nerve Injury, run by NHS National Waiting Times Centre Board at 1 site in United Kingdom.
Trial summary
Traditionally, coronary angiograms are performed through the radial artery which is accessed above the palm of the 'right' hand. In recent years, some cardiologists are performing this procedure from the back of the wrist in as the radial artery courses through the anatomical snuffbox (distal radial access). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Occlusion, Nerve Injury
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2019to 31 Dec 2020
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients for inclusion are those by whom coronary angiography or angioplasty is indicated as part of clinical decision-making or therapy. Operators with adequate experience at the discretion of the principal investigator in distal radial access are eligible to participate.
Who may be able to join
- Age ≥ 18 years.
- The distal radial artery must be palpable and non-occlusive flow must be confirmed by Doppler ultrasound.
- Patient should be able to comply with the protocol.
- Provide written informed consent before study participation.
Who cannot join
- Obligatory femoral or forearm radial access
- Previous ipsilateral forearm radial artery occlusion.
- Undergoing another procedure involving the ipsilateral radial artery, performed between the index procedure and the follow-up date.
- Enrolment in another study that competes or interferes with this study.
- Poor clinical condition like cardiogenic shock, that prohibits pre- and postprocedural function tests.
- Any other condition which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
- Co-morbidity that excludes patient follow-up.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Glasgow/Golden Jubilee Research Foundation
Glasgow, G12 8QQ
About this study
Official title: RATATOUILLE Study (inteRnATional hAnd funcTiOn stUdy Following dIstaL radiaL accEss)
Traditionally, coronary angiograms are performed through the radial artery which is accessed above the palm of the 'right' hand. In recent years, some cardiologists are performing this procedure from the back of the wrist in as the radial artery courses through the anatomical snuffbox (distal radial access). The aim of this study is to determine the prevalence of hand dysfunction following coronary angiography via the distal radial artery.
Read the detailed description
In this multi centre observational registry, we will recruit patients undergoing planned invasive coronary angiography. Inclusion criteria include:
- Age ≥ 18 years.
- The distal radial artery must be palpable and non-occlusive flow must be confirmed by Doppler ultrasound.
- Patient should be able to comply with the protocol.
- Provide written informed consent before study participation.
The primary endpoint is the overall prevalence of hand dysfunction defined as any significant reduction from baseline score in any of the following five domains:
DASH score Levine Katz score VAS score Sensory function Pinch grip strength.
Specifically hand function will be assessed at 4 time points using simple tests of hand strength, sensation and ultrasound to assess the arterial latency.
- Conditions
- Radial Artery Occlusion, Nerve Injury
- Keywords
- Invasive coronary angiography, Distal transradial arterial access, Anatomical snuffbox, dTRA, dRA, Distal radial, Radial artery occlusion
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Distal transradial arterial access | Patients undergoing invasive coronary angiography via the distal radial approach (anatomical snuffbox) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hand dysfunction
Any significant deterioration from baseline in hand function according to the 5 studied domains.
Measured: 1 month
Secondary outcomes (6)
Success of distal radial access
Successful introduction of sheath
Measured: Day 0
Vascular access complications (other than occlusion and bleeding)
Surgical complications or clinically important vascular access complications
Measured: Day 0
Puncture time
Time from skin puncture to successful placement of wire into the artery
Measured: Day 0
Radial artery occlusion - including level of occlusion (prox/distal)
USS guide
Measured: 0-12 months
Fluoroscopy time
Minutes
Measured: Day 0
Hemostasis duration
Minutes
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery OcclusionStudies 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
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- NHS National Waiting Times Centre Board
- Sponsor type
- University, hospital or other
- Collaborators
- MC Zuiderzee
- Responsible party
- Principal investigator, Dr Thomas J Ford, University of Glasgow
- Investigators
- Ferdinand Kiemeneij, MD, Principal investigator, MC ZuiderzeeAhmed Hassan, MD, Study director, MC Zuiderzee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789279
- Sponsor's protocol ID
- 18-WS-0182
- Other IDs
- 245250
- Acronym
- RATATOUILLE
- Status last verified
- Mar 2021
- First submitted
- 26 Dec 2018
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RATATOUILLE Study (inteRnATional hAnd funcTiOn stUdy Following dIstaL radiaL accEss)
- ClinicalTrials.gov ID
- NCT03789279
- Acronym / sponsor ID
- RATATOUILLE / 18-WS-0182
- Conditions
- Radial Artery Occlusion, Nerve Injury
- Keywords
- Invasive coronary angiography, Distal transradial arterial access, Anatomical snuffbox, dTRA, dRA, Distal radial, Radial artery occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NHS National Waiting Times Centre BoardUniversity, hospital or other
- Collaborators
- MC Zuiderzee
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Dec 2018 (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.
Traditionally, coronary angiograms are performed through the radial artery which is accessed above the palm of the 'right' hand. In recent years, some cardiologists are performing this procedure from the back of the wrist in as the radial artery courses through the anatomical snuffbox (distal radial access). The aim of this study is to determine the prevalence of hand dysfunction following coronary angiography via the distal radial artery.
Detailed description
In this multi centre observational registry, we will recruit patients undergoing planned invasive coronary angiography. Inclusion criteria include:
- Age ≥ 18 years.
- The distal radial artery must be palpable and non-occlusive flow must be confirmed by Doppler ultrasound.
- Patient should be able to comply with the protocol.
- Provide written informed consent before study participation.
The primary endpoint is the overall prevalence of hand dysfunction defined as any significant reduction from baseline score in any of the following five domains:
DASH score Levine Katz score VAS score Sensory function Pinch grip strength.
Specifically hand function will be assessed at 4 time points using simple tests of hand strength, sensation and ultrasound to assess the arterial latency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distal transradial arterial access | – | –Patients undergoing invasive coronary angiography via the distal radial approach (anatomical snuffbox) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients for inclusion are those by whom coronary angiography or angioplasty is indicated as part of clinical decision-making or therapy. Operators with adequate experience at the discretion of the principal investigator in distal radial access are eligible to participate.
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- The distal radial artery must be palpable and non-occlusive flow must be confirmed by Doppler ultrasound.
- Patient should be able to comply with the protocol.
- Provide written informed consent before study participation.
Key exclusion criteria (7 listed)
- Obligatory femoral or forearm radial access
- Previous ipsilateral forearm radial artery occlusion.
- Undergoing another procedure involving the ipsilateral radial artery, performed between the index procedure and the follow-up date.
- Enrolment in another study that competes or interferes with this study.
- Poor clinical condition like cardiogenic shock, that prohibits pre- and postprocedural function tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of hand dysfunction
Time frame: 1 month
Any significant deterioration from baseline in hand function according to the 5 studied domains.
6 secondary outcomes
Success of distal radial access
Time frame: Day 0
Vascular access complications (other than occlusion and bleeding)
Time frame: Day 0
Puncture time
Time frame: Day 0
Radial artery occlusion - including level of occlusion (prox/distal)
Time frame: 0-12 months
Fluoroscopy time
Time frame: Day 0
Hemostasis duration
Time frame: Day 0
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 9 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Radial Artery Occlusion
Recruiting
DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention
Vascular Access Site Occlusion
Recruiting
Randomization of Single vs Multiple Arterial Grafts
Coronary Artery Disease, Heart Diseases
RecruitingObservational study
Radial Access Data in Vascular Interventions Registry
Radial Artery Occlusion, Radial Artery Spasm
Not yet recruitingPhase 4
SPARK Study - Sympathetic Periarterial Radial Block in Healthy Volunteers
Healthy Volunteers, Sympathetic Activity
Recruiting
Timing of Anticoagulant Administration During Radial Access Percutaneous Coronary Intervention: the HERA-PCI Study (Heparin Early for Radial Access Percutaneous Coronary Intervention)
Coronary Angiography, Percutaneous Coronary Intervention
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.
Ferdinand Kiemeneij, MD principal investigator
MC Zuiderzee
Ahmed Hassan, MD study director
MC Zuiderzee
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 Occlusion and Nerve Injury, run by NHS National Waiting Times Centre Board at 1 site in United Kingdom.
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 4 inclusion and 7 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 9 Mar 2021. 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 United Kingdom. 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?
Prevalence of hand dysfunction (time frame: 1 month). 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 9 Mar 2021.