Clinical trial NCT03789279: Observational Study of Hand Function After Distal Transradial Access for Angiography
Official title: RATATOUILLE Study (inteRnATional hAnd funcTiOn stUdy Following dIstaL radiaL accEss)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radial Artery Occlusion
Nerve Injury
Keywords: Invasive coronary angiography
Distal transradial arterial access
Anatomical snuffbox
dTRA
dRA
Distal radial
Radial artery occlusion
Lead sponsor: NHS National Waiting Times Centre Board
Sponsor class: OTHER
Collaborators: name: MC Zuiderzee
First posted: 2018-12-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Prevalence of hand dysfunction
timeFrame: 1 month
Secondary outcomes:
measure: Success of distal radial access
timeFrame: Day 0
measure: Vascular access complications (other than occlusion and bleeding)
timeFrame: Day 0
measure: Puncture time
timeFrame: Day 0
measure: Radial artery occlusion - including level of occlusion (prox/distal)
timeFrame: 0-12 months
measure: Fluoroscopy time
timeFrame: Day 0
measure: Hemostasis duration
timeFrame: Day 0
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow/Golden Jubilee Research Foundation
Study officials:
affiliation: MC Zuiderzee
name: Ferdinand Kiemeneij, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MC Zuiderzee
name: Ahmed Hassan, MD
role: STUDY_DIRECTOR
References: