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

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ClinicalTrials.gov Identifier: NCT03789279
Recruitment Status : Active, not recruiting
First Posted : December 28, 2018
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
MC Zuiderzee
Information provided by (Responsible Party):
Dr Thomas J Ford, University of Glasgow

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.

Condition or disease
Radial Artery Occlusion Nerve Injury

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Observational Study of Hand Function After Distal Transradial Access for Angiography
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Group/Cohort
Distal transradial arterial access
Patients undergoing invasive coronary angiography via the distal radial approach (anatomical snuffbox)



Primary Outcome Measures :
  1. Prevalence of hand dysfunction [ Time Frame: 1 month ]
    Any significant deterioration from baseline in hand function according to the 5 studied domains.


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789279


Locations
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United Kingdom
University of Glasgow/Golden Jubilee Research Foundation
Glasgow, United Kingdom, G12 8QQ
Sponsors and Collaborators
NHS National Waiting Times Centre Board
MC Zuiderzee
Investigators
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Principal Investigator: Ferdinand Kiemeneij, MD MC Zuiderzee
Study Director: Ahmed Hassan, MD MC Zuiderzee

Additional Information:

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Responsible Party: Dr Thomas J Ford, Honorary Clinical Lecturer, University of Glasgow
ClinicalTrials.gov Identifier: NCT03789279     History of Changes
Other Study ID Numbers: 18-WS-0182
245250 ( Other Identifier: IRAS )
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Thomas J Ford, University of Glasgow:
Invasive coronary angiography
Distal transradial arterial access
Anatomical snuffbox
dTRA
dRA
Distal radial
Radial artery occlusion
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases