Single-centre prospective cohort study of patients presenting with severe limb ischaemia (SLI). The primary outcome measure will be 12 month major amputation rate. A historical cohort of patients identified retrospectively will be the comparitor group used to assess the impact of a newly-established rapid-access limb salvage clinic.
Primary aim:
\- Determine the proportion of patients with SLI undergoing major lower limb amputation within 12 months of presentation.
Secondary aims:
* Assess clinically important short-, medium- and long-term outcomes in those undergoing and not undergoing amputation * Prevalence and degree of frailty and cognitive impairment * Pevalence and degree of cardiac disease (detected by stress MRI) * Establish a biobank for future biomarker analysis * Investigate the role of frailty and cognitive assessments, cardiac MRI and biomarkers in risk-stratification of patients with SLI
All patients presenting to the Leicester Vascular Institute with SLI
SLI not caused by PAOD
Patients undergoing intervention during their index presentation prior to recruitment
Patients lacking capacity to consent with no accompanying next of kin, relative, partner or friend who can act as a personal consulted
Patients who cannot read, write or understand English
As representative a sample of patients presenting to the Leicester Vascular Institute with SLI during the study period as possible. All patients presenting with SLI within the age criteria will be eligible and personal consultee consent will allow recruitment even of those patients lacking capacity to consent.
Cohort
Prospective
Not listed
12 month amputation rate
Proportion of patients undergoing major lower limb amputation
Amputation free survival
Composite outcome measure of death or amputation
All-cause mortality
Death from any cause
Quality of life
Quality of life as measured by the Vascular Quality of Life questionnaire (VascuQoL) * 25 item questionnaire, score 1-7 for each item, higher score = better quality of life * Domains: activities (8 items), symptoms (4 items), pain (4 items), social (2 items) and emotional (7 items); each scored 1-7 (total of domain item scores/number of items) * Overall score 1-7 (total item score/25)
Disability
Level of disability as measured by the Barthel Index \- Score 0-20; higher score = greater degree of functional independence/lower level of disability
Cognitive impairment (Frailty & Cognitive additional assessments only)
Prevalence of cognitive impairment as detected by the Montreal Cognitive Assessment (MoCA) * Score 0-30; highger score = greater level of cognitive function * Results will also be reported dichotomised to normal (score ≥24) and cognitive impairment (score ≤23)
Post-operative delirium (Frailty & Cognitive additional assessments only)
Incidence of post-operative delirium as detected by the Single Question in Delirium (SQiD) +/- 4 A's Test for delirium (4AT)
Prevalence of coronary artery disease (Cardiac MR additional assessments only)
Prevalence of coronary artery disease as detected by stress cardiac MRI
Incidence of peri-operative myocardial infarction (Cardiac MR additional assessments only)
Incidence of peri-operative myocardial infarction as detected by cardiac MRI
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University of Leicester
Lead sponsor
University Hospitals, Leicester
Collaborator
National Institute for Health Research, United Kingdom
Collaborator
The George Davies Charitable Trust
Collaborator
