Leg ischaemia management collaboration (LIMb): study protocol for a prospective cohort study at a single UK centre

John S M Houghton, Sarah Nduwayo, Andrew T O Nickinson, Tanya J Payne, Sue Sterland, Mintu Nath, Laura J Gray, Greg S McMahon, Harjeet S Rayt, Sally J Singh, Thompson G Robinson, Simon P Conroy, Victoria J Haunton, Gerry P McCann, Matthew J Bown, Robert S M Davies, Rob D Sayers, John S M Houghton, Sarah Nduwayo, Andrew T O Nickinson, Tanya J Payne, Sue Sterland, Mintu Nath, Laura J Gray, Greg S McMahon, Harjeet S Rayt, Sally J Singh, Thompson G Robinson, Simon P Conroy, Victoria J Haunton, Gerry P McCann, Matthew J Bown, Robert S M Davies, Rob D Sayers

Abstract

Introduction: Severe limb ischaemia (SLI) is the end stage of peripheral arterial occlusive disease where the viability of the limb is threatened. Around 25% of patients with SLI will ultimately require a major lower limb amputation, which has a substantial adverse impact on quality of life. A newly established rapid-access vascular limb salvage clinic and modern revascularisation techniques may reduce amputation rate. The aim of this study was to investigate the 12-month amputation rate in a contemporary cohort of patients and compare this to a historical cohort. Secondary aims are to investigate the use of frailty and cognitive assessments, and cardiac MRI in risk-stratifying patients with SLI undergoing intervention and establish a biobank for future biomarker analyses.

Methods and analysis: This single-centre prospective cohort study will recruit patients aged 18-110 years presenting with SLI. Those undergoing intervention will be eligible to undergo additional venepuncture (for biomarker analysis) and/or cardiac MRI. Those aged ≥65 years and undergoing intervention will also be eligible to undergo additional frailty and cognitive assessments. Follow-up will be at 12 and 24 months and subsequently via data linkage with NHS Digital to 10 years postrecruitment. Those undergoing cardiac MRI and/or frailty assessments will receive additional follow-up during the first 12 months to investigate for perioperative myocardial infarction and frailty-related outcomes, respectively. A sample size of 420 patients will be required to detect a 10% reduction in amputation rate in comparison to a similar sized historical cohort, with 90% power and 5% type I error rate. Statistical analysis of this comparison will be by adjusted and unadjusted logistic regression analyses.

Ethics and dissemination: Ethical approval for this study has been granted by the UK National Research Ethics Service (19/LO/0132). Results will be disseminated to participants via scientific meetings, peer-reviewed medical journals and social media.

Trial registration number: NCT04027244.

Keywords: biomarkers; cognitive dysfunction; frailty; limb salvage; myocardial perfusion imaging; peripheral arterial disease.

Conflict of interest statement

Competing interests: RSMD has acted as a speaker for Gore Medical and has received educational grants from Terumo/Aortic outside the submitted work.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study overview. Numbers are estimates for the whole 2-year recruitment period and based on local audit data from 2018/2019.
Figure 2
Figure 2
Cardiac MRI protocol including Dixon function for abdominal visceral and subcutaneous fat. L3, third lumbar vertebra; 4/3/2 Ch, 4/3/2 chamber; SAO, sagittal oblique.

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