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Coronary Artery Bypass GraftingNCT06433960

Radial Artery Assessment in Surgical Coronary Revascularisation

An observational study of Coronary Artery Bypass Grafting and Coronary Artery Disease, run by Papworth Hospital NHS Foundation Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to learn about how screening tests inform the radial artery (RA) suitability for harvesting and coronary bypass grafting in adults with ischaemic heart disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Modified Allen Test, Pulse-oximetry guided Modified Allen Test and Barbeau Test
How many people
77 participants
Where
2 sitesUnited Kingdom
Study dates
10 Jul 2024to 31 Mar 2025
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: People with ischaemic heart disease undergoing coronary bypass surgery and radial artery harvest at Royal Papworth and Royal Brompton hospitals will be invited to participate in this study.

Who may be able to join

  • Male and female adults patients undergoing elective or urgent coronary artery bypass graft (CABG) surgery and radial artery (RA) harvesting in two Cardiothoracic hospitals.

Who cannot join

  • Paediatric patients and/or adult patients undergoing emergency CABG will not be considered within the participants of this cross-sectional study, as well as patients lacking capacity to consent and non-English speaking patients requiring use of interpreters. Patients not wishing to participate in the study will also not be recruited.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites
  • Royal Papworth Hospital

    Cambridge, England/Cambridgeshire, CB20AY

  • Royal Brompton Hospital

    London, England, SW3 6NP

Other trials in United Kingdom

About this study

Official title: A Cross-Sectional Study and a Novel Screening Survey for Radial Artery Assessment in Surgical Coronary Revascularisation

The goal of this observational study is to learn about how screening tests inform the radial artery (RA) suitability for harvesting and coronary bypass grafting in adults with ischaemic heart disease. The main question it aims to answer is:

  • What factors influence the diagnostic accuracy of RA screening in patients undergoing surgical coronary revascularisation?

Participants will:

  • Receive an assessment of their RA through routinely used techniques (Modified Allen Test +/- pulse-oximetry, Barbeau Test and Ultrasound examination)
  • Answer a symptoms scale about their physical experience after surgery
Read the detailed description

A multi-centre cross-sectional study design to investigate the validity of radial artery (RA) assessment techniques in adults with ischaemic heart disease undergoing surgical coronary revascularisation with their RA being selected as an autologous graft conduit.

Patients taking part in the study will receive an assessment of the arterial forearm circulation from their non-dominant upper extremity through multiple observations.

Pre-operative observations. Before surgery (in the ward environment after the patient is being admitted or whilst patient in the anaesthetic room) the forearm blood circulation is measured through a Modified Allen Test (MAT) (+/- pulse-oximetry), Barbeau Test and Ultrasonography examination. Assessment will be performed by experienced Surgical Care Practitioners/Advanced Nurse Practitioners/Cardiac Specialist Registrars. These assessments will inform the decision to surgically expose the RA.

Intra-operative observations. Oxygen saturation readings are taken prior to harvest the RA. Once the RA is surgically harvested a series of measures are taken through a validated structured questionnaire: the Radial Artery Quality Evaluation Survey (RAQES).

Observations at 4-6 weeks post operation. Patients finger movements, cold tolerance sensitivity and tactile/touch perception is measured through an ordinal symptoms scale (Follow-up Radial Artery Harvesting Scale) at post-operative day 2-5 and at follow-up appointment (3-6 weeks after surgery). Bilateral comparison between hands and forearms will be undertaken. A Surgical Care Practitioner will perform this assessment post-operatively.

Consecutive sampling will be used for the recruitment of study participants. The minimum required number of participants to test and verify research hypotheses is sixty-nine patients (N=69). An adaptive trial design will be implemented: at quarterly assessment points the statistical power is assessed and the remaining sample size required is updated accordingly.

Sample size calculation was undertaken using G*Power software (version 3.1) using Chi-squared Test and adopting optimal effect size (w=0.4) and power (0.8).

Descriptive and inferential statistics will be used to perform quantitative analyses. Descriptive statistics (mode, median) will be implemented to analyse RAQES answers and ordinal symptoms scale findings and cross-tabulation used to record relationship between variables. Data analysis will also include measurement of sensitivity, specificity, positive and negative predictive values to investigate the validity of the RA assessment techniques. Correlational analysis will be implemented and Receiver Operating Characteristic curve analysis will be used to compare the diagnostic accuracy of the MAT, pulse-oximetry guided MAT and Barbeau Test with the ultrasonography examination.

Being tested
Modified Allen Test, Pulse-oximetry guided Modified Allen Test, Barbeau Test, Ultrasound examination of the forearm arteries, Measurement of oxygen saturation
Keywords
Radial Artery, Modified Allen Test, Barbeau Test, Ultrasonography
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.

  • Modified Allen TestDiagnostic test

    Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 1 minute.

    Instruct the patient to clench their wrist while the examiner occlude with three fingers the patients ulnar and radial arteries; instruct the patient to unclench their wrist; release the ulnar artery. The MAT result is negative or positive considering in how long the palm flushes:

    ≤5 seconds: negative MAT; good collateral hand circulation (suggesting harvestable radial artery).

    greater than 5 seconds: positive MAT; poor collateral hand circulation (suggesting not-harvestable radial artery).

  • Pulse-oximetry guided Modified Allen TestDiagnostic test

    Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 1 minute.

    A pulse-oximetry probe is positioned on the patients index finger; both radial and ulnar arteries are occluded by the examiner (with three fingers) until flattening of pulse waveform is obtained. Pressure on the ulnar artery is released and the result of the assessment is calculated considering in how long the pulse waveform returns to baseline:

    ≤5 seconds: negative result (suggesting harvestable radial artery). greater than 5 seconds: positive result (suggesting not harvestable radial artery).

    (Busti and Kellogg, 2015)

  • Barbeau TestDiagnostic test

    Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 2 minutes.

    A pulse-oximetry probe is positioned on the patients thumb; the radial artery is then compressed by the examiner, and the pulse waveform is analysed for up to 120 seconds, providing four result patterns of ulno-palmar patency:

    1. No damping of the pulse tracing immediately after compression (suggesting harvestable radial artery)
    2. Damping of the pulse tracing (suggesting harvestable radial artery)
    3. Loss of the pulse tracing, followed by recovery within 120 sec (suggesting harvestable radial artery)
    4. Loss of the pulse tracing, without recovery within 120 sec (suggesting not harvestable radial artery). (Zalocar et al., 2020)
  • Ultrasound examination of the forearm arteriesDiagnostic test

    Pre-operative intervention aimed at evaluating morphological characteristics (diameter, presence of calcifications) of the radial and ulnar arteries. Duration: 5 minutes.

    The radial artery is surgically exposed (negative result) when the following apply:

    1. ulnar artery inner diameter ≥2 mm
    2. radial artery inner diameter ≥2 mm
    3. absence of radial artery intraluminal calcifications and plaques. (Vukovic et al., 2017)
  • Measurement of oxygen saturationDiagnostic test

    Intra-operative intervention aimed at evaluating the blood oxygen level in the hand if the radial artery was harvested. Duration: 1 minute.

    The radial artery is surgically harvested when the oxygen saturation reading (SpO2) from the thumb through pulse-oximetry remains at 95% or above when an occlusive atraumatic clamp is applied on the mobilised radial artery.

  • Radial Artery Quality Evaluation SurveyOther

    Intra-operative intervention (validated structured questionnaire) aimed at evaluating anatomical and physiological characteristics of the radial artery and suitability for coronary graft implantation.

    The radial artery is surgically harvested when its morphology and pathology (diameter, calcifications, presence of pulsatile flow), quality of harvesting technique and surgical accessibility are considered satisfactory, good or optimal.

    The Radial Artery Quality Evaluation Survey is completed by surgical care practitioners.

  • Follow-up Radial Artery Harvesting ScaleOther

    Postoperative intervention (ordinal symptoms scale) aimed at evaluating patients finger movements, cold tolerance sensitivity and tactile/touch perception at post-operative day 2 to 5 and at follow-up appointment (3-6 weeks after surgery). Bilateral comparison between hands and forearms is undertaken. Tactile perception is assessed through monofilaments (single touch). Cold sensitivity is assessed through the use of ice-pack.

    The Follow-up Radial Artery Harvesting Scale was developed from a verbal rating scale (VRS) questionnaire documented in the literature. The VRS questionnaire was re-adapted to appreciate people postoperative experience with their finger movements, cold sensitivity and tactile/touch perception of their forearm.

Study groups in NCT06433960
Study groupRoleWhat they receive
Cardiovascular sample groupCardiac patients undergoing elective or urgent coronary artery bypass graft surgery and radial artery harvest in two Cardiothoracic hospitals.
Receives: Diagnostic Test: Modified Allen Test; Diagnostic Test: Pulse-oximetry guided Modified Allen Test; Diagnostic Test: Barbeau Test; Diagnostic Test: Ultrasound examination of the forearm arteries; Diagnostic Test: Measurement of oxygen saturation; Other: Radial Artery Quality Evaluation Survey; Other: Follow-up Radial Artery Harvesting Scale

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity of Radial Artery Assessment Techniques

    Measure the sensitivity of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination.

    Measured: From enrollment to the end of treatment at 12 weeks.

  2. Specificity of Radial Artery Assessment Techniques

    Measure the specificity of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination.

    Measured: From enrollment to the end of treatment at 12 weeks.

  3. Negative and Positive predictive values of Radial Artery Assessment Techniques

    Measure the negative and positive predictive values of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination.

    Measured: From enrollment to the end of treatment at 12 weeks.

Secondary outcomes (2)
  1. Radial Artery Quality Evaluation

    Measure the morphological and physiological quality of radial arteries through a validated structured questionnaire (Radial Artery Quality Evaluation Survey)

    Measured: From enrollment to surgical harvesting of the radial artery at day 1-2 after hospitalisation.

  2. Patients Physical Experience Evaluation

    Measure the patients' finger movements, cold tolerance sensitivity and tactile/touch perception through an ordinal symptoms scale (Follow-up Radial Artery Harvesting Scale).

    Measured: From day of surgery to the end of treatment at 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2024
  2. Study start10 Jul 2024
  3. Primary completion8 Jan 2025
  4. Study completion31 Mar 2025

Resources

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
Other
Time perspective
Prospective
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06433960
Sponsor's protocol ID
24/SC/0076
Status last verified
Aug 2025
First submitted
23 May 2024
Last updated
5 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication. Shared IPD will be presented in a de-identified (anonymised) format for each participant and will include information about interventions or tests received and outcomes observed.

Publications

  • Zalocar LAD, Doroszuk G, Goland J. Transradial approach and its variations for neurointerventional procedures: Literature review. Surg Neurol Int. 2020 Aug 15;11:248. doi: 10.25259/SNI_366_2020. eCollection 2020.

    PubMed 32905334
  • Vukovic P, Peric M, Radak S, Aleksic N, Unic-Stojanovic D, Micovic S, Stojanovic I, Milojevic P. Preoperative Insight Into the Quality of Radial Artery Grafts. Angiology. 2017 Oct;68(9):790-794. doi: 10.1177/0003319716686014. Epub 2017 Jan 5.

    PubMed 28056520

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Bypass Grafting and Coronary Artery Disease, run by Papworth Hospital NHS Foundation Trust at 2 sites 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 1 inclusion and 1 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 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Sensitivity of Radial Artery Assessment Techniques (time frame: From enrollment to the end of treatment at 12 weeks.). The study lists 3 primary outcomes in all. 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 NCT06433960, 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 5 Aug 2025.

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