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

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.

SUBMITTER: Houghton JSM

PROVIDER: S-EPMC6731919 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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

Houghton John S M JSM Nduwayo Sarah S Nickinson Andrew T O ATO Payne Tanya J TJ Sterland Sue S Nath Mintu M Gray Laura J LJ McMahon Greg S GS Rayt Harjeet S HS Singh Sally J SJ Robinson Thompson G TG Conroy Simon P SP Haunton Victoria J VJ McCann Gerry P GP Bown Matthew J MJ Davies Robert S M RSM Sayers Rob D RD

BMJ open 20190903 9

<h4>Introduction</h4>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 ...[more]

PMID: 31481569

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Dataset Information

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

Publications

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

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