Leg Ischaemia Management Collaboration
Recruiting now
Conditions studied: Peripheral Arterial Disease, Critical Limb Ischemia, Frailty, Cognitive Impairment, Coronary Artery Disease
In brief
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
Key facts
- Study ID
- NCT04027244
- Run by
- University of Leicester
- People needed
- 420
- Starts
- 2019-05-10
- Expected to finish
- 2031-05-09
- Last updated by the study team
- 2020-11-04
Who can join
Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients presenting to the Leicester Vascular Institute with SLI
You may not qualify if…
- 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
Where it is running
- Glenfield Hospital Leicester — Leicester, Leicestershire, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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