Status:
RECRUITING
Leg Ischaemia Management Collaboration
Lead Sponsor:
University of Leicester
Collaborating Sponsors:
University Hospitals, Leicester
National Institute for Health Research, United Kingdom
Conditions:
Peripheral Arterial Disease
Critical Limb Ischemia
Eligibility:
All Genders
18-110 years
Brief 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 iden...
Detailed 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 ischae...
Eligibility Criteria
Inclusion
- PRIMARY COHORT
- All patients presenting to the Leicester Vascular Institute with SLI
Exclusion
- 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
Key Trial Info
Start Date :
May 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 9 2031
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04027244
Start Date
May 10 2019
End Date
May 9 2031
Last Update
November 4 2020
Active Locations (1)
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1
Glenfield Hospital Leicester
Leicester, Leicestershire, United Kingdom, LE3 9QP