Coronary Artery Disease Clinical Trial
— LIMbOfficial title:
Leg Ischaemia Management Collaboration
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 |
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
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Glenfield Hospital Leicester | Leicester | Leicestershire |
Lead Sponsor | Collaborator |
---|---|
University of Leicester | National Institute for Health Research, United Kingdom, The George Davies Charitable Trust, University Hospitals, Leicester |
United Kingdom,
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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