## Protocol Section
### Identification Module
**NCT ID:** NCT03789279

**Acronym:** RATATOUILLE

**Brief Title:** Observational Study of Hand Function After Distal Transradial Access for Angiography

**Official Title:** RATATOUILLE Study (inteRnATional hAnd funcTiOn stUdy Following dIstaL radiaL accEss)

#### Organization Study ID Info
**ID:** 18-WS-0182
#### Organization
**Class:** OTHER
**Full Name:** NHS National Waiting Times Centre Board
#### Secondary ID Infos
**Domain:** IRAS
**ID:** 245250
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2020-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-03-09

**Type:** ACTUAL

**Last Update Submit Date:** 2021-03-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2019-01-01

**Type:** ACTUAL

**Status Verified Date:** 2021-03

#### Study First Post Date
**Date:** 2018-12-28
**Type:** ACTUAL
**Study First Submit Date:** 2018-12-26
**Study First Submit QC Date:** 2018-12-27
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** MC Zuiderzee

#### Lead Sponsor

**Class:** OTHER

**Name:** NHS National Waiting Times Centre Board

#### Responsible Party

**Investigator Affiliation:** University of Glasgow

**Investigator Full Name:** Dr Thomas J Ford

**Investigator Title:** Honorary Clinical Lecturer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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). 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:

1. Age ≥ 18 years.
2. The distal radial artery must be palpable and non-occlusive flow must be confirmed by Doppler ultrasound.
3. Patient should be able to comply with the protocol.
4. 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 Module

**Conditions:**

- Radial Artery Occlusion

- Nerve Injury

**Keywords:**

- Invasive coronary angiography

- Distal transradial arterial access

- Anatomical snuffbox

- dTRA

- dRA

- Distal radial

- Radial artery occlusion

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 12 Months

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients undergoing invasive coronary angiography via the distal radial approach (anatomical snuffbox)

**Label:** Distal transradial arterial access

### Outcomes Module

#### Primary Outcomes

**Description:** Any significant deterioration from baseline in hand function according to the 5 studied domains.

**Measure:** Prevalence of hand dysfunction

**Time Frame:** 1 month

#### Secondary Outcomes

**Description:** Successful introduction of sheath

**Measure:** Success of distal radial access

**Time Frame:** Day 0

**Description:** Surgical complications or clinically important vascular access complications

**Measure:** Vascular access complications (other than occlusion and bleeding)

**Time Frame:** Day 0

**Description:** Time from skin puncture to successful placement of wire into the artery

**Measure:** Puncture time

**Time Frame:** Day 0

**Description:** USS guide

**Measure:** Radial artery occlusion - including level of occlusion (prox/distal)

**Time Frame:** 0-12 months

**Description:** Minutes

**Measure:** Fluoroscopy time

**Time Frame:** Day 0

**Description:** Minutes

**Measure:** Hemostasis duration

**Time Frame:** Day 0

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age ≥ 18 years.
2. The distal radial artery must be palpable and non-occlusive flow must be confirmed by Doppler ultrasound.
3. Patient should be able to comply with the protocol.
4. Provide written informed consent before study participation.

Exclusion Criteria:

1. Obligatory femoral or forearm radial access
2. Previous ipsilateral forearm radial artery occlusion.
3. Undergoing another procedure involving the ipsilateral radial artery, performed between the index procedure and the follow-up date.
4. Enrolment in another study that competes or interferes with this study.
5. Poor clinical condition like cardiogenic shock, that prohibits pre- and postprocedural function tests.
6. 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.
7. Co-morbidity that excludes patient follow-up.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Glasgow

**Country:** United Kingdom

**Facility:** University of Glasgow/Golden Jubilee Research Foundation

**Zip:** G12 8QQ

#### Overall Officials

**Official 1:**

**Affiliation:** MC Zuiderzee

**Name:** Ferdinand Kiemeneij, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** MC Zuiderzee

**Name:** Ahmed Hassan, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: HIGH

- As Found: Artery Occlusion

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001157

- Term: Arterial Occlusive Diseases

### Misc Info Module

- Version Holder: 2024-05-24
