Cognitive Impairment, Coronary Artery Disease, Critical Limb Ischemia, Frailty, Peripheral Arterial Disease
Conditions
Keywords
Peripheral arterial disease, Limb salvage, Frailty, Cognitive dysfunction, Myocardial perfusion imaging, Biomarkers
Brief summary
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
Detailed description
Severe limb ischaemia (SLI) is the end-stage of peripheral arterial occlusive disease (PAOD) whereby the viability of the limb is threatened due to the degree of arterial disease and subsequent ischaemia in the peripheral tissues. It is defined as ischaemic rest pain (or night pain) and/or ulceration or gangrene in the affected limb(s) for a minimum of two weeks attributed to confirmed PAOD. Treatment includes open surgical and endovascular revascularisation, with or without surgical debridement of affected tissues, amputation of toes and drainage of sepsis. In some patients revascularisation is not possible or fails resulting in the person requiring a major lower limb amputation. Over 4000 major lower limb amputations per year were undertaken in England alone between 2003 and 2013 and a diabetes-related major lower limb amputation is performed every 30 seconds world-wide. As many as 25% of people with SLI will undergo a major lower limb amputation in the first year after presentation. Amputation negatively affects quality of life due to its negative impact on mobility, independence and ability to carry out activities of daily living. This single-centre prospective cohort study will investigate the amputation rate at one year in patients presenting with SLI and compare this to a retrospectively identified historical cohort. This study will also investigate the prevelance and degree of frailty, cognitive impairment, and cardiac disease (detected by cardiac magnetic resonance imaging (MRI)), as well as establish a biobank for future biomarker analyses. The role of frailty and cognitive assessments, cardiac MRI and biomarker analysis in risk-stratifying patients with SLI will also be investigated.
Interventions
None listed
Sponsors
University Hospitals, Leicester
National Institute for Health Research, United Kingdom
The George Davies Charitable Trust
University of Leicester
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
PRIMARY COHORT Inclusion Criteria: * All patients presenting to the Leicester Vascular Institute with SLI
Exclusion criteria
* 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 * Any significant disease or disorder which may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study FRAILTY & COGNITIVE ADDITIONAL ASSESSMENTS Inclusion criteria: * Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention for SLI * Patients aged ≥65 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12 month amputation rate | 12 months post recruitment | Proportion of patients undergoing major lower limb amputation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | ≥12 months | Death from any cause |
| Amputation free survival | ≥12 months post recruitment | Composite outcome measure of death or amputation |
| Quality of life | 12 and 24 months post recruitment | 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 | 12 and 24 months post recruitment | Level of disability as measured by the Barthel Index \- Score 0-20; higher score = greater degree of functional independence/lower level of disability |
| Clinical Frailty Scale | Baseline, 12 and 24 months | Prevalence and degree of frailty as measured by the Clinical Frailty Scale (CFS) * Score 1-9, higher score = greater degree of frailty * Results will also be reported dichotomised to frail (score ≥5) and non-frail (score ≤4) |
| Anxiety & Depression | Baseline, 12 and 24 months | Prevalence and degree of anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS) * 14 item questionnaire; score 0-3 for each item, higher score = more severe anxiety/depression * Domains: Depression (7 items), Anxiety (7 items); each scored 0-21; 0-7 = normal, 8-10 = bordeline, 11-21 = abnormal (case). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cognitive impairment (Frailty & Cognitive additional assessments only) | Baseline, 3 and 12 months | 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) | 24 and 72 hours post intervention | Incidence of post-operative delirium as detected by the Single Question in Delirium (SQiD) +/- 4 A's Test for delirium (4AT) |
| Edmonton Frail Scale (Frailty & Cognitive additional assessments only) | Baseline, 3 and 12 months | Prevalence and degree of frailty as measured by the Edmonton Frail Scale (EFS) * Score 0-17, 0-5 = not frail, 6-7 = vulnerable, 8-9 = mild frailty, 10-11 = moderate frailty, 12-17 = severe frailty * Results will also be reported dichotomised to frail (score ≥8) and non-frail (score ≤7) |
| Incidence of peri-operative myocardial infarction (Cardiac MR additional assessments only) | 2-4 months post intervention | Incidence of peri-operative myocardial infarction as detected by cardiac MRI |
| Prevalence of coronary artery disease (Cardiac MR additional assessments only) | Baseline | Prevalence of coronary artery disease as detected by stress cardiac MRI |
Countries
United Kingdom
Contacts
Primary ContactRob D Sayers, MD
Backup ContactTanya J Payne, BSc
Outcome results
None listed