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
|Condition or disease|
|Radial Artery Occlusion Nerve Injury|
In this multi centre observational registry, we will recruit patients undergoing planned invasive coronary angiography. Inclusion criteria include:
- 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.
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||40 participants|
|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|
Distal transradial arterial access
Patients undergoing invasive coronary angiography via the distal radial approach (anatomical snuffbox)
- Prevalence of hand dysfunction [ Time Frame: 1 month ]Any significant deterioration from baseline in hand function according to the 5 studied domains.
- Success of distal radial access [ Time Frame: Day 0 ]Successful introduction of sheath
- Vascular access complications (other than occlusion and bleeding) [ Time Frame: Day 0 ]Surgical complications or clinically important vascular access complications
- Puncture time [ Time Frame: Day 0 ]Time from skin puncture to successful placement of wire into the artery
- Radial artery occlusion - including level of occlusion (prox/distal) [ Time Frame: 0-12 months ]USS guide
- Fluoroscopy time [ Time Frame: Day 0 ]Minutes
- Hemostasis duration [ Time Frame: Day 0 ]Minutes
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
|University of Glasgow/Golden Jubilee Research Foundation|
|Glasgow, United Kingdom, G12 8QQ|
|Principal Investigator:||Ferdinand Kiemeneij, MD||MC Zuiderzee|
|Study Director:||Ahmed Hassan, MD||MC Zuiderzee|