Observational Study of Hand Function After Distal Transradial Access for Angiography (RATATOUILLE)

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.

Study Overview

• Status: Completed
• Conditions: Nerve Injury; Radial Artery Occlusion

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G12 8QQ
    • University of Glasgow/Golden Jubilee Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Distal transradial arterial access; Patients undergoing invasive coronary angiography via the distal radial approach (anatomical snuffbox)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of hand dysfunction	Any significant deterioration from baseline in hand function according to the 5 studied domains.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of distal radial access	Successful introduction of sheath	Day 0
Vascular access complications (other than occlusion and bleeding)	Surgical complications or clinically important vascular access complications	Day 0
Puncture time	Time from skin puncture to successful placement of wire into the artery	Day 0
Radial artery occlusion - including level of occlusion (prox/distal)	USS guide	0-12 months
Fluoroscopy time	Minutes	Day 0
Hemostasis duration	Minutes	Day 0

Collaborators and Investigators

• Sponsor: NHS National Waiting Times Centre Board
• Collaborators: MC Zuiderzee
• Investigators: Principal Investigator: Ferdinand Kiemeneij, MD, MC Zuiderzee; Study Director: Ahmed Hassan, MD, MC Zuiderzee

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: December 26, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (Actual): December 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 7, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Radial artery occlusion; Invasive coronary angiography; Distal transradial arterial access; Anatomical snuffbox; dTRA; dRA; Distal radial
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: 18-WS-0182; 245250 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No