Observational Study of Hand Function After Distal Transradial Access for Angiography

Nerve Injury Clinical Trial

— RATATOUILLE  

Official title:

RATATOUILLE Study (inteRnATional hAnd funcTiOn stUdy Following dIstaL radiaL accEss)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789279
• Other study ID #: 18-WS-0182
• Secondary ID: 245250
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: NHS National Waiting Times Centre Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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). The aim of this study is to determine the prevalence of hand dysfunction following coronary angiography via the distal radial artery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Nerve Injury
• Radial Artery Occlusion

Locations

Country	Name	City	State
United Kingdom	University of Glasgow/Golden Jubilee Research Foundation	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS National Waiting Times Centre Board	MC Zuiderzee

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of hand dysfunction	Any significant deterioration from baseline in hand function according to the 5 studied domains.	1 month
Secondary	Success of distal radial access	Successful introduction of sheath	Day 0
Secondary	Vascular access complications (other than occlusion and bleeding)	Surgical complications or clinically important vascular access complications	Day 0
Secondary	Puncture time	Time from skin puncture to successful placement of wire into the artery	Day 0
Secondary	Radial artery occlusion - including level of occlusion (prox/distal)	USS guide	0-12 months
Secondary	Fluoroscopy time	Minutes	Day 0
Secondary	Hemostasis duration	Minutes	Day 0