Leg Ischaemia Management Collaboration

NCT04027244 | Recruiting

• 1 other identifier: 0686
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

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 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

Peripheral Arterial Disease; Critical Limb Ischemia; Frailty; Cognitive Impairment; Coronary Artery Disease

Keywords

Peripheral arterial disease; Limb salvage; Frailty; Cognitive dysfunction; Myocardial perfusion imaging; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 12 month amputation rate

  Proportion of patients undergoing major lower limb amputation

  12 months post recruitment

Secondary Outcomes (6)

• Amputation free survival

  ≥12 months post recruitment

• All-cause mortality

  ≥12 months

• Quality of life

  12 and 24 months post recruitment

• Disability

  12 and 24 months post recruitment

• Clinical Frailty Scale

  Baseline, 12 and 24 months

Other Outcomes (5)

• Cognitive impairment (Frailty & Cognitive additional assessments only)

  Baseline, 3 and 12 months

• Post-operative delirium (Frailty & Cognitive additional assessments only)

  24 and 72 hours post intervention

• Prevalence of coronary artery disease (Cardiac MR additional assessments only)

  Baseline

Study Arms (5)

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).

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As representative a sample of patients presenting to the Leicester Vascular Institute with SLI during the study period as possible. All patients presenting with SLI within the age criteria will be eligible and personal consultee consent will allow recruitment even of those patients lacking capacity to consent.

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
• Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention for SLI
• Patients aged ≥65 years
• Nil additional
• CARDIAC MRI ADDITIONAL ASSESSMENTS
• Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention
• 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

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• The George Davies Charitable Trust: collaborator

Study Sites (1)

Glenfield Hospital Leicester

Leicester, Leicestershire, LE3 9QP, United Kingdom

RECRUITING

Related Publications (1)

• Houghton JSM, Nduwayo S, Nickinson ATO, Payne TJ, Sterland S, Nath M, Gray LJ, McMahon GS, Rayt HS, Singh SJ, Robinson TG, Conroy SP, Haunton VJ, McCann GP, Bown MJ, Davies RSM, Sayers RD. Leg ischaemia management collaboration (LIMb): study protocol for a prospective cohort study at a single UK centre. BMJ Open. 2019 Sep 3;9(9):e031257. doi: 10.1136/bmjopen-2019-031257.

  PMID: 31481569 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and Plasma samples.

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Frailty; Cognitive Dysfunction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Coronary Disease; Myocardial Ischemia; Heart Diseases

Study Officials

• Rob D Sayers, MD

  University of Leicester

  STUDY CHAIR

Central Study Contacts

Rob D Sayers, MD

CONTACT

+44 (0)116 252 3141; rs152@le.ac.uk

Tanya J Payne, BSc

CONTACT

+44 (0)116 258 3867; tjp28@le.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 19, 2019
• Study Start: May 10, 2019
• Primary Completion: May 9, 2022
• Study Completion (Estimated): May 9, 2031
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

GB (1)