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Leg Ischaemia Management Collaboration (LIMb)

3 de noviembre de 2020 actualizado por: 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

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Anticipado)

420

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Rob D Sayers, MD
  • Número de teléfono: +44 (0)116 252 3141
  • Correo electrónico: rs152@le.ac.uk

Copia de seguridad de contactos de estudio

  • Nombre: Tanya J Payne, BSc
  • Número de teléfono: +44 (0)116 258 3867
  • Correo electrónico: tjp28@le.ac.uk

Ubicaciones de estudio

  • Reino Unido
    • Leicestershire
      • Leicester, Leicestershire, Reino Unido, LE3 9QP
        • Reclutamiento
        • Glenfield Hospital Leicester
        • Sub-Investigador:
          • Gerry P McCann, MD
        • Contacto:
          • Tanya J Payne
          • Número de teléfono: +44 (0)116 358 3867
          • Correo electrónico: tjp28@le.ac.uk
        • Investigador principal:
          • Rob D Sayers, MD
        • Sub-Investigador:
          • Matt J Bown, MD
        • Sub-Investigador:
          • Thompson G Robinson, MD
        • Sub-Investigador:
          • Victoria J Haunton, MD
        • Sub-Investigador:
          • Sally J Singh, PhD
        • Investigador principal:
          • Robert SM Davies, MD
        • Sub-Investigador:
          • Tanya J Payne, BSc
        • Sub-Investigador:
          • Laura J Gray, PhD
        • Sub-Investigador:
          • Harjeet S Rayt, MD
        • Sub-Investigador:
          • Gregory S McMahon, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 110 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / 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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
12 month amputation rate
Periodo de tiempo: 12 months post recruitment
Proportion of patients undergoing major lower limb amputation
12 months post recruitment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Amputation free survival
Periodo de tiempo: ≥12 months post recruitment
Composite outcome measure of death or amputation
≥12 months post recruitment
All-cause mortality
Periodo de tiempo: ≥12 months
Death from any cause
≥12 months
Quality of life
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Cognitive impairment (Frailty & Cognitive additional assessments only)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline
Prevalence of coronary artery disease as detected by stress cardiac MRI
Baseline
Incidence of peri-operative myocardial infarction (Cardiac MR additional assessments only)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Leicester

Colaboradores

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

Investigadores

  • Silla de estudio: Rob D Sayers, MD, University of Leicester

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de mayo de 2019

Finalización primaria (Anticipado)

9 de mayo de 2022

Finalización del estudio (Anticipado)

9 de mayo de 2031

Fechas de registro del estudio

Enviado por primera vez

11 de julio de 2019

Primero enviado que cumplió con los criterios de control de calidad

18 de julio de 2019

Publicado por primera vez (Actual)

19 de julio de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

3 de noviembre de 2020

Última verificación

1 de noviembre de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 0686

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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