Department of Cardiovascular Sciences, University of Leicester, Leicester, UK
Leicester Vascular Institute, University Hospitals of Leicester NHS Trust, Leicester, UK.
BMJ Open. 2019 Sep 3;9(9):e031257. doi: 10.1136/bmjopen-2019-031257.
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.
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.
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.
NCT04027244.
严重肢体缺血（SLI）是外周动脉闭塞性疾病的终末期，肢体的存活受到威胁。大约 25%的 SLI 患者最终需要进行大肢体截肢，这对生活质量有很大的不利影响。新建立的快速通道血管肢体挽救诊所和现代血运重建技术可能会降低截肢率。本研究的目的是调查当代队列中患者的 12 个月截肢率，并与历史队列进行比较。次要目的是研究在接受干预的 SLI 患者中进行脆弱性和认知评估以及心脏 MRI 的使用情况，并为未来的生物标志物分析建立生物库。
这项单中心前瞻性队列研究将招募出现 SLI 的 18-110 岁患者。接受干预的患者将有资格进行额外的静脉穿刺（用于生物标志物分析）和/或心脏 MRI。年龄≥65 岁并接受干预的患者也有资格进行额外的脆弱性和认知评估。随访时间为 12 个月和 24 个月，随后通过与 NHS Digital 进行数据链接，随访时间为招募后 10 年。接受心脏 MRI 和/或脆弱性评估的患者将在最初的 12 个月内进行额外的随访，以分别调查围手术期心肌梗死和与脆弱性相关的结果。需要 420 名患者的样本量才能检测到与类似大小的历史队列相比，截肢率降低 10%，具有 90%的功效和 5%的Ⅰ类错误率。比较结果的统计分析将通过调整和未调整的逻辑回归分析进行。
本研究已获得英国国家研究伦理服务机构（19/LO/0132）的批准。结果将通过科学会议、同行评议的医学期刊和社交媒体向参与者传播。
NCT04027244。
