Leg Ischaemia Management Collaboration

Status: Recruiting
Location: See location...
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 110
Healthy Volunteers: f
View:

• All patients presenting to the Leicester Vascular Institute with SLI

• Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention for SLI

• Patients aged ≥65 years

• Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention

Locations
Other Locations
United Kingdom
Glenfield Hospital Leicester
RECRUITING
Leicester
Contact Information
Primary
Rob D Sayers, MD
rs152@le.ac.uk
+44 (0)116 252 3141
Backup
Tanya J Payne, BSc
tjp28@le.ac.uk
+44 (0)116 258 3867
Time Frame
Start Date: 2019-05-10
Estimated Completion Date: 2031-05-09
Participants
Target number of participants: 420
Treatments
Primary cohort
Any patient presenting to the Leicester Vascular Institute with SLI during the 2 year recruitment period (minimum 420 patients).
Frailty & cognitive additional assessments
Any patient recruited to the primary cohort aged ≥65 years and undergoing an intervention for SLI (minimum 150 patients, target 210 patients).
Cardiac MRI additional assessments
Any patient recruited to the primary cohort, with capacity to consent and undergoing an intervention for SLI (minimum 100 patients).
Biomarkers additional assessments
Any patient recruited to the primary cohort and undergoing an intervention for SLI (no target recruitment set).
Historical cohort
Retrospectively identified cohort of patients presenting to the study site with SLI between 2013 -15 (target 420).
Sponsors
Leads: University of Leicester
Collaborators: The George Davies Charitable Trust, University Hospitals, Leicester, National Institute for Health Research, United Kingdom

This content was sourced from clinicaltrials.gov