Observational Study of Hand Function After Distal Transradial Access for Angiography
NCT ID: NCT03789279
Last Updated: 2021-03-09
Study Results
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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COMPLETED
40 participants
OBSERVATIONAL
2019-01-01
2020-12-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
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
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.
18 Years
ALL
No
Sponsors
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MC Zuiderzee
UNKNOWN
NHS National Waiting Times Centre Board
OTHER
Responsible Party
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Dr Thomas J Ford
Honorary Clinical Lecturer
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
Countries
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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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