Waveform assessment for surveillance post arterial revascularisation
Research type
Research Study
Full title
Ankle Arterial Doppler Waveform Assessment For Surveillance Following Lower Limb Revascularisation
IRAS ID
339909
Contact name
Hamidah Alodayni
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Ankle Doppler waveform assessment has been shown to be an easy, safe and accurate test for diagnosing narrowed or blocked arteries (peripheral arterial disease; PAD). It is also a promising tool for monitoring patients following lower limb operations to improve blood flow (revascularisation). Currently, following such operations, patients are monitored by performing regular ultrasound scans. These are performed by experts in hospital and are costly. If ankle Doppler waveform assessment (a focused/ abbreviated ultrasound scan) was shown to be accurate, it could allow for more regular monitoring outside of the hospital setting.
This study aims to assess the diagnostic performance of serial visual Doppler ankle waveform assessment in detecting significant arterial blockages or stenosis following lower limb revascularisation (using two different handheld devices), compared to a full arterial lower limb Duplex Ultrasound.
Patients presenting to Imperial College Health NHS Trust and planned for lower limb revascularisation procedures will be eligible for recruitment. We aim to recruit 121 patients. Participants will undergo 12 months of observation, integrated into their routine visits. All study visits will coincide with the procedure and follow-ups at 3, 6, and 12 months after the revascularisation. At the first visit, demographic data, medical history, and clinical assessments are collected. Follow-up visits include routine surveillance duplex ultrasound scans (reference test) which are performed as part of standard care and also the ankle waveform assessments (index tests) being evaluated in this study.
The accuracy of the index tests will be calculated by comparing their results to that of the reference test.
REC name
London - Hampstead Research Ethics Committee
REC reference
24/LO/0462
Date of REC Opinion
2 Jul 2024
REC opinion
Further Information Favourable Opinion