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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04027244
Other study ID # 0686
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 10, 2019
Est. completion date May 9, 2031

Study information

Verified date November 2020
Source University of Leicester
Contact Rob D Sayers, MD
Phone +44 (0)116 252 3141
Email rs152@le.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 420
Est. completion date May 9, 2031
Est. primary completion date May 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility 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 Exclusion criteria: - Nil additional CARDIAC MRI ADDITIONAL ASSESSMENTS Inclusion criteria: - Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention Exclusion criteria: - Absolute contraindications to cardiac MRI (Pregnancy, Non-MR safe permanent pacemaker, implanted cardiac defibrillator, intra-auricular implant or intra-cranial clips, severe claustrophobia, unstable angina) - Contraindication to gadolinium contrast agent (Known adverse reaction, chronic renal failure (eGFR <30mL/min/1.73m^2)) - Patients lacking capacity to consent for cardiac MRI BIOMARKERS ADDITIONAL ASSESSMENTS - Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention Exclusion criteria: - Nil additional

Study Design


Locations

Country Name City State
United Kingdom Glenfield Hospital Leicester Leicester Leicestershire

Sponsors (4)

Lead Sponsor Collaborator
University of Leicester National Institute for Health Research, United Kingdom, The George Davies Charitable Trust, University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other 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)
Baseline, 3 and 12 months
Other 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) 24 and 72 hours post intervention
Other Prevalence of coronary artery disease (Cardiac MR additional assessments only) Prevalence of coronary artery disease as detected by stress cardiac MRI Baseline
Other Incidence of peri-operative myocardial infarction (Cardiac MR additional assessments only) Incidence of peri-operative myocardial infarction as detected by cardiac MRI 2-4 months post intervention
Other Edmonton Frail Scale (Frailty & Cognitive additional assessments only) 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)
Baseline, 3 and 12 months
Primary 12 month amputation rate Proportion of patients undergoing major lower limb amputation 12 months post recruitment
Secondary Amputation free survival Composite outcome measure of death or amputation =12 months post recruitment
Secondary All-cause mortality Death from any cause =12 months
Secondary 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)
12 and 24 months post recruitment
Secondary Disability Level of disability as measured by the Barthel Index
- Score 0-20; higher score = greater degree of functional independence/lower level of disability
12 and 24 months post recruitment
Secondary Clinical Frailty Scale 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)
Baseline, 12 and 24 months
Secondary Anxiety & Depression 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).
Baseline, 12 and 24 months
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