Observational Study of Hand Function After Distal Transradial Access for Angiography

Completed

• Conditions: Radial Artery Occlusion; Nerve Injury

• Registration Number: NCT03789279
• Lead Sponsor: NHS National Waiting Times Centre Board

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.

Study Timeline

• Study First Submitted: 2018-12-26
• Study First Submitted QC: 2018-12-27
• Study First Posted: 2018-12-28
• Study Start: 2019-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-07
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of hand dysfunction	1 month	Any significant deterioration from baseline in hand function according to the 5 studied domains.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Glasgow/Golden Jubilee Research Foundation; 🇬🇧 Glasgow, United Kingdom