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Observational Study of Hand Function After Distal Transradial Access for Angiography (RATATOUILLE)

N

NHS National Waiting Times Centre Board

Status

Completed

Conditions

Radial Artery Occlusion
Nerve Injury

Study type

Observational

Funder types

Other

Identifiers

NCT03789279
18-WS-0182
245250 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

Distal transradial arterial access
Description:
Patients undergoing invasive coronary angiography via the distal radial approach (anatomical snuffbox)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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