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Leg Ischaemia Management Collaboration (LIMb)

3 novembre 2020 mis à jour par: 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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

420

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

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

Sauvegarde des contacts de l'étude

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

Lieux d'étude

  • Royaume-Uni
    • Leicestershire
      • Leicester, Leicestershire, Royaume-Uni, LE3 9QP
        • Recrutement
        • Glenfield Hospital Leicester
        • Sous-enquêteur:
          • Gerry P McCann, MD
        • Contact:
          • Tanya J Payne
          • Numéro de téléphone: +44 (0)116 358 3867
          • E-mail: tjp28@le.ac.uk
        • Chercheur principal:
          • Rob D Sayers, MD
        • Sous-enquêteur:
          • Matt J Bown, MD
        • Sous-enquêteur:
          • Thompson G Robinson, MD
        • Sous-enquêteur:
          • Victoria J Haunton, MD
        • Sous-enquêteur:
          • Sally J Singh, PhD
        • Chercheur principal:
          • Robert SM Davies, MD
        • Sous-enquêteur:
          • Tanya J Payne, BSc
        • Sous-enquêteur:
          • Laura J Gray, PhD
        • Sous-enquêteur:
          • Harjeet S Rayt, MD
        • Sous-enquêteur:
          • Gregory S McMahon, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 110 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
12 month amputation rate
Délai: 12 months post recruitment
Proportion of patients undergoing major lower limb amputation
12 months post recruitment

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Amputation free survival
Délai: ≥12 months post recruitment
Composite outcome measure of death or amputation
≥12 months post recruitment
All-cause mortality
Délai: ≥12 months
Death from any cause
≥12 months
Quality of life
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Cognitive impairment (Frailty & Cognitive additional assessments only)
Délai: 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)
Délai: 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)
Délai: Baseline
Prevalence of coronary artery disease as detected by stress cardiac MRI
Baseline
Incidence of peri-operative myocardial infarction (Cardiac MR additional assessments only)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Leicester

Collaborateurs

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

Les enquêteurs

  • Chaise d'étude: Rob D Sayers, MD, University of Leicester

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 mai 2019

Achèvement primaire (Anticipé)

9 mai 2022

Achèvement de l'étude (Anticipé)

9 mai 2031

Dates d'inscription aux études

Première soumission

11 juillet 2019

Première soumission répondant aux critères de contrôle qualité

18 juillet 2019

Première publication (Réel)

19 juillet 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 novembre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2020

Dernière vérification

1 novembre 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 0686

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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