## Protocol Section
### Identification Module
**NCT ID:** NCT06433960

**Brief Title:** Radial Artery Assessment in Surgical Coronary Revascularisation

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

#### Organization Study ID Info
**ID:** 24/SC/0076
#### Organization
**Class:** OTHER_GOV
**Full Name:** Papworth Hospital NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2025-02-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-02-28

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-28

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Papworth Hospital NHS Foundation Trust

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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. 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

**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.

### Conditions Module

**Conditions:**

- Coronary Artery Bypass Grafting

- Coronary Artery Disease

**Keywords:**

- Radial Artery

- Modified Allen Test

- Barbeau Test

- Ultrasonography

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 69

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Cardiac patients undergoing elective or urgent coronary artery bypass graft surgery and radial artery harvest in two Cardiothoracic hospitals.

**Intervention Names:**

- 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

**Label:** Cardiovascular sample group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cardiovascular sample group

**Description:** 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).

**Name:** Modified Allen Test

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Cardiovascular sample group

**Description:** 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)

**Name:** Pulse-oximetry guided Modified Allen Test

**Type:** DIAGNOSTIC_TEST

#### Intervention 3

**Arm Group Labels:**

- Cardiovascular sample group

**Description:** 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)

**Name:** Barbeau Test

**Type:** DIAGNOSTIC_TEST

#### Intervention 4

**Arm Group Labels:**

- Cardiovascular sample group

**Description:** 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)

**Name:** Ultrasound examination of the forearm arteries

**Type:** DIAGNOSTIC_TEST

#### Intervention 5

**Arm Group Labels:**

- Cardiovascular sample group

**Description:** 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.

**Name:** Measurement of oxygen saturation

**Type:** DIAGNOSTIC_TEST

#### Intervention 6

**Arm Group Labels:**

- Cardiovascular sample group

**Description:** 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.

**Name:** Radial Artery Quality Evaluation Survey

**Type:** OTHER

#### Intervention 7

**Arm Group Labels:**

- Cardiovascular sample group

**Description:** 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.

**Name:** Follow-up Radial Artery Harvesting Scale

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Sensitivity of Radial Artery Assessment Techniques

**Time Frame:** From enrollment to the end of treatment at 12 weeks.

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

**Measure:** Specificity of Radial Artery Assessment Techniques

**Time Frame:** From enrollment to the end of treatment at 12 weeks.

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

**Measure:** Negative and Positive predictive values of Radial Artery Assessment Techniques

**Time Frame:** From enrollment to the end of treatment at 12 weeks.

#### Secondary Outcomes

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

**Measure:** Radial Artery Quality Evaluation

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

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

**Measure:** Patients Physical Experience Evaluation

**Time Frame:** From day of surgery to the end of treatment at 12 weeks.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** vincenzo.defranco@nhs.net

**Name:** Vincenzo De Franco, MSc SCP

**Phone:** +441223638000

**Role:** CONTACT

**Contact 2:**

**Email:** naim.abdulmohdi@aru.ac.uk

**Name:** Naim Abdulmohdi, PhD

**Phone:** +441223695538

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cambridge

**Contacts:**

***Contact 1:***

- **Name:** Vincenzo De Franco

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Royal Papworth Hospital

**State:** England/Cambridgeshire

**Zip:** CB20AY

**Location 2:**

**City:** London

**Contacts:**

***Contact 1:***

- **Name:** Vincenzo De Franco

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Royal Brompton Hospital

**State:** England

**Zip:** SW3 6NP

#### Overall Officials

**Official 1:**

**Affiliation:** Royal Papworth Hospital NHS Foundation Trust

**Name:** Vincenzo De Franco, MSc SCP

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Researchers wishing to conduct a diagnostic accuracy analysis of the tests (interventions) under investigation car require copy of the anonymised IPD and supporting information to the principal investigator.

A proposal describing the planned analysis must be provided and a data sharing agreement form (requested to the sponsoring institution) must be signed.

Further instructions for obtaining access are available at the link below:

https://royalpapworth.nhs.uk/research-and-development or contacting: papworth.randdadmin@nhs.net

**Description:** 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.

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** Beginning 6 months and ending 3 years after the publication of results.

**URL:** https://royalpapworth.nhs.uk/research-and-development

### References Module

#### References

**Citation:** 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.

**PMID:** 32905334

**Citation:** 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.

**PMID:** 28056520

#### See Also Links

**Label:** Busti, A.J. and Kellogg, D. (2015) Allens Test.

**URL:** https://www.ebmconsult.com/articles/physica-exam-allens-test

**Label:** Kinoue, T. and Arai, M. (2021) Comparison of Rating Scale Methods for Cold Sensation in Kampo Medicine, International Medical Journal, 28(1), pp.94-97.

**URL:** https://seronjihou.files.wordpress.com/2021/05/281094.pdf

## Document Section

### Large Document Module

#### Large Docs

- Date: 2024-04-09

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 408471

- Type Abbrev: Prot_SAP

- Upload Date: 2024-05-23T08:51

- Date: 2024-05-23

- Filename: ICF_002.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 122008

- Type Abbrev: ICF

- Upload Date: 2024-05-29T07:46

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003327

- Term: Coronary Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

### Misc Info Module

- Version Holder: 2024-05-31
