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. 2019 Sep 3;9(9):e031257.
doi: 10.1136/bmjopen-2019-031257.

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

John S M Houghton  1   2   3 , Sarah Nduwayo  4   2   3 , Andrew T O Nickinson  4   2   3 , Tanya J Payne  4   3 , Sue Sterland  4   3 , Mintu Nath  4   3 , Laura J Gray  5 , Greg S McMahon  4   2 , Harjeet S Rayt  4   2 , Sally J Singh  6 , Thompson G Robinson  4   3 , Simon P Conroy  5 , Victoria J Haunton  4 , Gerry P McCann  4   3 , Matthew J Bown  4   2   3 , Robert S M Davies  4   2 , Rob D Sayers  4   2   3
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Leg ischaemia management collaboration (LIMb): study protocol for a prospective cohort study at a single UK centre

John S M Houghton et al. BMJ Open. .

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.

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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.

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.
See this image and copyright information in PMC

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References

    1. Fowkes FGR, Rudan D, Rudan I, et al. . Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. The Lancet 2013;382:1329–40. 10.1016/S0140-6736(13)61249-0 - DOI - PubMed
    1. Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res 2015;116:1509–26. 10.1161/CIRCRESAHA.116.303849 - DOI - PubMed
    1. Becker F, Robert-Ebadi H, Ricco J-B, et al. . Chapter I: definitions, epidemiology, clinical presentation and prognosis. European Journal of Vascular and Endovascular Surgery 2011;42(Suppl 2):S4–S12. 10.1016/S1078-5884(11)60009-9 - DOI - PubMed
    1. Norgren L, Hiatt WR, Dormandy JA, et al. . Inter-Society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007;45 Suppl S:S5–67. - PubMed
    1. Ahmad N, Thomas GN, Gill P, et al. . The prevalence of major lower limb amputation in the diabetic and non-diabetic population of England 2003–2013. Diabetes and Vascular Disease Research 2016;13:348–53. 10.1177/1479164116651390 - DOI - PubMed

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