Leg ischaemia management collaboration (LIMb): study protocol for a prospective cohort study at a single UK centre. Issue 9 (3rd September 2019)

• Record Type: Journal Article
• Authors: Houghton, John S M; Nduwayo, Sarah; Nickinson, Andrew T O; Payne, Tanya J; Sterland, Sue; Nath, Mintu; Gray, Laura J; McMahon, Greg S; Rayt, Harjeet S; Singh, Sally J; Robinson, Thompson G; Conroy, Simon P; Haunton, Victoria J; McCann, Gerry P; Bown, Matthew J; Davies, Robert S M; Sayers, Rob D
• Is Part Of: BMJ open. Volume 9:Issue 9(2019)
• Publication Date: 2019-09-03
• Subjects: peripheral arterial disease -- limb salvage -- frailty -- cognitive dysfunction -- myocardial perfusion imaging -- biomarkers; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-031257
• Languages: English
• ISSNs: 2044-6055

Abstract

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 .