Leg Ischaemia Management Collaboration

Coronary Artery Disease Clinical Trial

— LIMb  

Official title:

Leg Ischaemia Management Collaboration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04027244
• Other study ID #: 0686
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cognitive Impairment
• Coronary Artery Disease
• Critical Limb Ischemia
• Frailty
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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