Actively Recruiting
Leg Ischaemia Management Collaboration
Led by University of Leicester · Updated on 2020-11-04
420
Participants Needed
1
Research Sites
626 weeks
Total Duration
On this page
Sponsors
U
University of Leicester
Lead Sponsor
U
University Hospitals, Leicester
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Leg Ischaemia Management Collaboration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients presenting to the Leicester Vascular Institute with severe limb ischaemia
- Patients aged 65 years or older undergoing intervention for severe limb ischaemia (for frailty and cognitive assessments)
- Patients undergoing intervention for severe limb ischaemia (for cardiac MRI and biomarker assessments)
You will not qualify if you...
- Severe limb ischaemia not caused by peripheral arterial occlusive disease
- Patients treated with intervention during the current hospital visit before recruitment
- Patients unable to consent without a personal consultee available
- Patients unable to read, write, or understand English
- Any serious disease or disorder that may increase risk or affect study participation or results
- Absolute contraindications to cardiac MRI, including pregnancy, non-MR safe devices, implants, severe claustrophobia, or unstable angina
- Contraindication to gadolinium contrast agent, such as known allergy or severe kidney failure
- Patients unable to consent for cardiac MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Glenfield Hospital Leicester
Leicester, Leicestershire, United Kingdom, LE3 9QP
Actively Recruiting
Research Team
R
Rob D Sayers, MD
CONTACT
T
Tanya J Payne, BSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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