ArticleBMJ open2019
Leg ischaemia management collaboration (LIMb): study protocol for a prospective cohort study at a single UK centre.
Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04027244 (Leg Ischaemia Management Collaboration), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Leg Ischaemia Management Collaboration
Who cites it
0 citing papers in PubMed, 8 citations in OpenAlex.
No citing paper in PubMed yet.
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Authors and funding
17 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSevere 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.
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