Observational Study of Hand Function After Distal Transradial Access for Angiography

NCT ID: NCT03789279

Last Updated: 2021-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Radial Artery Occlusion Nerve Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Distal transradial arterial access

Patients undergoing invasive coronary angiography via the distal radial approach (anatomical snuffbox)

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MC Zuiderzee

UNKNOWN

Sponsor Role collaborator

NHS National Waiting Times Centre Board

OTHER

Sponsor Role lead

Responsible Party

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Dr Thomas J Ford

Honorary Clinical Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ferdinand Kiemeneij, MD

Role: PRINCIPAL_INVESTIGATOR

MC Zuiderzee

Ahmed Hassan, MD

Role: STUDY_DIRECTOR

MC Zuiderzee

Locations

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University of Glasgow/Golden Jubilee Research Foundation

Glasgow, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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245250

Identifier Type: OTHER

Identifier Source: secondary_id

18-WS-0182

Identifier Type: -

Identifier Source: org_study_id

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