Observational Study of Hand Function After Distal Transradial Access for Angiography

Study Overview
=================
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: Age ≥ 18 years. The distal radial artery must be palpable and non-occlusive flow must be confirmed by Doppler ultrasound. Patient should be able to comply with the protocol. 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.

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

Conditions
-----------------
Radial Artery Occlusion, Nerve Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years. The distal radial artery must be palpable and non-occlusive flow must be confirmed by Doppler ultrasound. Patient should be able to comply with the protocol. Provide written informed consent before study participation. Exclusion Criteria: Obligatory femoral or forearm radial access Previous ipsilateral forearm radial artery occlusion. Undergoing another procedure involving the ipsilateral radial artery, performed between the index procedure and the follow-up date. Enrolment in another study that competes or interferes with this study. Poor clinical condition like cardiogenic shock, that prohibits pre- and postprocedural function tests. 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. Co-morbidity that excludes patient follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Distal transradial arterial access<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dRA, dTRA, Invasive coronary angiography, Distal transradial arterial access, Anatomical snuffbox, Distal radial, Radial artery occlusion