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Completed

NCT Number: NCT03789279

Observational Study of Hand Function After Distal Transradial Access for Angiography

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Glasgow/Golden Jubilee Research Foundation

Glasgow, G12 8QQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence of hand dysfunction

    Time frame: 1 month

    Any significant deterioration from baseline in hand function according to the 5 studied domains.

Secondary outcomes

  1. Success of distal radial access

    Time frame: Day 0

    Successful introduction of sheath

  2. Vascular access complications (other than occlusion and bleeding)

    Time frame: Day 0

    Surgical complications or clinically important vascular access complications

  3. Puncture time

    Time frame: Day 0

    Time from skin puncture to successful placement of wire into the artery

  4. Radial artery occlusion - including level of occlusion (prox/distal)

    Time frame: 0-12 months

    USS guide

  5. Fluoroscopy time

    Time frame: Day 0

    Minutes

  6. Hemostasis duration

    Time frame: Day 0

    Minutes

Sponsors and collaborators

Lead sponsor

NHS National Waiting Times Centre Board

Other

Collaborators

  • MC Zuiderzee

Registry information

Official study title

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

Acronym: RATATOUILLE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 28, 2018
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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