Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Leg Ischaemia Management Collaboration (LIMb)

3 novembre 2020 aggiornato da: 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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Anticipato)

420

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Rob D Sayers, MD
  • Numero di telefono: +44 (0)116 252 3141
  • Email: rs152@le.ac.uk

Backup dei contatti dello studio

  • Nome: Tanya J Payne, BSc
  • Numero di telefono: +44 (0)116 258 3867
  • Email: tjp28@le.ac.uk

Luoghi di studio

  • Regno Unito
    • Leicestershire
      • Leicester, Leicestershire, Regno Unito, LE3 9QP
        • Reclutamento
        • Glenfield Hospital Leicester
        • Sub-investigatore:
          • Gerry P McCann, MD
        • Contatto:
          • Tanya J Payne
          • Numero di telefono: +44 (0)116 358 3867
          • Email: tjp28@le.ac.uk
        • Investigatore principale:
          • Rob D Sayers, MD
        • Sub-investigatore:
          • Matt J Bown, MD
        • Sub-investigatore:
          • Thompson G Robinson, MD
        • Sub-investigatore:
          • Victoria J Haunton, MD
        • Sub-investigatore:
          • Sally J Singh, PhD
        • Investigatore principale:
          • Robert SM Davies, MD
        • Sub-investigatore:
          • Tanya J Payne, BSc
        • Sub-investigatore:
          • Laura J Gray, PhD
        • Sub-investigatore:
          • Harjeet S Rayt, MD
        • Sub-investigatore:
          • Gregory S McMahon, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 110 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
12 month amputation rate
Lasso di tempo: 12 months post recruitment
Proportion of patients undergoing major lower limb amputation
12 months post recruitment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Amputation free survival
Lasso di tempo: ≥12 months post recruitment
Composite outcome measure of death or amputation
≥12 months post recruitment
All-cause mortality
Lasso di tempo: ≥12 months
Death from any cause
≥12 months
Quality of life
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Cognitive impairment (Frailty & Cognitive additional assessments only)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Baseline
Prevalence of coronary artery disease as detected by stress cardiac MRI
Baseline
Incidence of peri-operative myocardial infarction (Cardiac MR additional assessments only)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Leicester

Collaboratori

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

Investigatori

  • Cattedra di studio: Rob D Sayers, MD, University of Leicester

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 maggio 2019

Completamento primario (Anticipato)

9 maggio 2022

Completamento dello studio (Anticipato)

9 maggio 2031

Date di iscrizione allo studio

Primo inviato

11 luglio 2019

Primo inviato che soddisfa i criteri di controllo qualità

18 luglio 2019

Primo Inserito (Effettivo)

19 luglio 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2020

Ultimo verificato

1 novembre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 0686

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Disfunsione dell'arteria coronaria

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Zambia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi