Observational Study of Hand Function After Distal Transradial Access for Angiography

NCT03789279 | Completed

• 2 other identifiers: 18-WS-0182245250
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Radial Artery Occlusion; Nerve Injury

Keywords

Invasive coronary angiography; Distal transradial arterial access; Anatomical snuffbox; dTRA; dRA; Distal radial; Radial artery occlusion

Outcome Measures

Primary Outcomes (1)

• Prevalence of hand dysfunction

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

  1 month

Secondary Outcomes (6)

• Success of distal radial access

  Day 0

• Vascular access complications (other than occlusion and bleeding)

  Day 0

• Puncture time

  Day 0

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

  0-12 months

• Fluoroscopy time

  Day 0

Study Arms (1)

Distal transradial arterial access

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS National Waiting Times Centre Board: lead
• MC Zuiderzee: collaborator

Study Sites (1)

University of Glasgow/Golden Jubilee Research Foundation

Glasgow, G12 8QQ, United Kingdom

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ferdinand Kiemeneij, MD

  MC Zuiderzee

  PRINCIPAL INVESTIGATOR

• Ahmed Hassan, MD

  MC Zuiderzee

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Lecturer

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 28, 2018
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)