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Leg Ischaemia Management Collaboration (LIMb)

3 november 2020 bijgewerkt door: University of Leicester

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

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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 ischaemia in the peripheral tissues. It is defined as ischaemic rest pain (or night pain) and/or ulceration or gangrene in the affected limb(s) for a minimum of two weeks attributed to confirmed PAOD. Treatment includes open surgical and endovascular revascularisation, with or without surgical debridement of affected tissues, amputation of toes and drainage of sepsis. In some patients revascularisation is not possible or fails resulting in the person requiring a major lower limb amputation.

Over 4000 major lower limb amputations per year were undertaken in England alone between 2003 and 2013 and a diabetes-related major lower limb amputation is performed every 30 seconds world-wide. As many as 25% of people with SLI will undergo a major lower limb amputation in the first year after presentation. Amputation negatively affects quality of life due to its negative impact on mobility, independence and ability to carry out activities of daily living.

This single-centre prospective cohort study will investigate the amputation rate at one year in patients presenting with SLI and compare this to a retrospectively identified historical cohort. This study will also investigate the prevelance and degree of frailty, cognitive impairment, and cardiac disease (detected by cardiac magnetic resonance imaging (MRI)), as well as establish a biobank for future biomarker analyses. The role of frailty and cognitive assessments, cardiac MRI and biomarker analysis in risk-stratifying patients with SLI will also be investigated.

Studietype

Observationeel

Inschrijving (Verwacht)

420

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Rob D Sayers, MD
  • Telefoonnummer: +44 (0)116 252 3141
  • E-mail: rs152@le.ac.uk

Studie Contact Back-up

  • Naam: Tanya J Payne, BSc
  • Telefoonnummer: +44 (0)116 258 3867
  • E-mail: tjp28@le.ac.uk

Studie Locaties

  • Verenigd Koninkrijk
    • Leicestershire
      • Leicester, Leicestershire, Verenigd Koninkrijk, LE3 9QP
        • Werving
        • Glenfield Hospital Leicester
        • Onderonderzoeker:
          • Gerry P McCann, MD
        • Contact:
          • Tanya J Payne
          • Telefoonnummer: +44 (0)116 358 3867
          • E-mail: tjp28@le.ac.uk
        • Hoofdonderzoeker:
          • Rob D Sayers, MD
        • Onderonderzoeker:
          • Matt J Bown, MD
        • Onderonderzoeker:
          • Thompson G Robinson, MD
        • Onderonderzoeker:
          • Victoria J Haunton, MD
        • Onderonderzoeker:
          • Sally J Singh, PhD
        • Hoofdonderzoeker:
          • Robert SM Davies, MD
        • Onderonderzoeker:
          • Tanya J Payne, BSc
        • Onderonderzoeker:
          • Laura J Gray, PhD
        • Onderonderzoeker:
          • Harjeet S Rayt, MD
        • Onderonderzoeker:
          • Gregory S McMahon, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 110 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

PRIMARY COHORT

Inclusion Criteria:

  • All patients presenting to the Leicester Vascular Institute with SLI

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
12 month amputation rate
Tijdsspanne: 12 months post recruitment
Proportion of patients undergoing major lower limb amputation
12 months post recruitment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Amputation free survival
Tijdsspanne: ≥12 months post recruitment
Composite outcome measure of death or amputation
≥12 months post recruitment
All-cause mortality
Tijdsspanne: ≥12 months
Death from any cause
≥12 months
Quality of life
Tijdsspanne: 12 and 24 months post recruitment

Quality of life as measured by the Vascular Quality of Life questionnaire (VascuQoL)

  • 25 item questionnaire, score 1-7 for each item, higher score = better quality of life
  • Domains: activities (8 items), symptoms (4 items), pain (4 items), social (2 items) and emotional (7 items); each scored 1-7 (total of domain item scores/number of items)
  • Overall score 1-7 (total item score/25)
12 and 24 months post recruitment
Disability
Tijdsspanne: 12 and 24 months post recruitment

Level of disability as measured by the Barthel Index

- Score 0-20; higher score = greater degree of functional independence/lower level of disability
12 and 24 months post recruitment
Clinical Frailty Scale
Tijdsspanne: Baseline, 12 and 24 months

Prevalence and degree of frailty as measured by the Clinical Frailty Scale (CFS)

  • Score 1-9, higher score = greater degree of frailty
  • Results will also be reported dichotomised to frail (score ≥5) and non-frail (score ≤4)
Baseline, 12 and 24 months
Anxiety & Depression
Tijdsspanne: Baseline, 12 and 24 months

Prevalence and degree of anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)

  • 14 item questionnaire; score 0-3 for each item, higher score = more severe anxiety/depression
  • Domains: Depression (7 items), Anxiety (7 items); each scored 0-21; 0-7 = normal, 8-10 = bordeline, 11-21 = abnormal (case).
Baseline, 12 and 24 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cognitive impairment (Frailty & Cognitive additional assessments only)
Tijdsspanne: Baseline, 3 and 12 months

Prevalence of cognitive impairment as detected by the Montreal Cognitive Assessment (MoCA)

  • Score 0-30; highger score = greater level of cognitive function
  • Results will also be reported dichotomised to normal (score ≥24) and cognitive impairment (score ≤23)
Baseline, 3 and 12 months
Post-operative delirium (Frailty & Cognitive additional assessments only)
Tijdsspanne: 24 and 72 hours post intervention
Incidence of post-operative delirium as detected by the Single Question in Delirium (SQiD) +/- 4 A's Test for delirium (4AT)
24 and 72 hours post intervention
Prevalence of coronary artery disease (Cardiac MR additional assessments only)
Tijdsspanne: Baseline
Prevalence of coronary artery disease as detected by stress cardiac MRI
Baseline
Incidence of peri-operative myocardial infarction (Cardiac MR additional assessments only)
Tijdsspanne: 2-4 months post intervention
Incidence of peri-operative myocardial infarction as detected by cardiac MRI
2-4 months post intervention
Edmonton Frail Scale (Frailty & Cognitive additional assessments only)
Tijdsspanne: Baseline, 3 and 12 months

Prevalence and degree of frailty as measured by the Edmonton Frail Scale (EFS)

  • Score 0-17, 0-5 = not frail, 6-7 = vulnerable, 8-9 = mild frailty, 10-11 = moderate frailty, 12-17 = severe frailty
  • Results will also be reported dichotomised to frail (score ≥8) and non-frail (score ≤7)
Baseline, 3 and 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Leicester

Medewerkers

University Hospitals, Leicester
National Institute for Health Research, United Kingdom
The George Davies Charitable Trust

Onderzoekers

  • Studie stoel: Rob D Sayers, MD, University of Leicester

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 mei 2019

Primaire voltooiing (Verwacht)

9 mei 2022

Studie voltooiing (Verwacht)

9 mei 2031

Studieregistratiedata

Eerst ingediend

11 juli 2019

Eerst ingediend dat voldeed aan de QC-criteria

18 juli 2019

Eerst geplaatst (Werkelijk)

19 juli 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2020

Laatste update ingediend die voldeed aan QC-criteria

3 november 2020

Laatst geverifieerd

1 november 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 0686

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

Anonymised dataset will be available on request to the Chief Investigator (Prof Rob Sayers). The study protocol will be published in an open-access journal prior to completion of recruitment.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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