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Leg Ischaemia Management Collaboration (LIMb)

3. november 2020 opdateret af: 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

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

420

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse Kontakt Backup

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

Studiesteder

  • Det Forenede Kongerige
    • Leicestershire
      • Leicester, Leicestershire, Det Forenede Kongerige, LE3 9QP
        • Rekruttering
        • Glenfield Hospital Leicester
        • Underforsker:
          • Gerry P McCann, MD
        • Kontakt:
          • Tanya J Payne
          • Telefonnummer: +44 (0)116 358 3867
          • E-mail: tjp28@le.ac.uk
        • Ledende efterforsker:
          • Rob D Sayers, MD
        • Underforsker:
          • Matt J Bown, MD
        • Underforsker:
          • Thompson G Robinson, MD
        • Underforsker:
          • Victoria J Haunton, MD
        • Underforsker:
          • Sally J Singh, PhD
        • Ledende efterforsker:
          • Robert SM Davies, MD
        • Underforsker:
          • Tanya J Payne, BSc
        • Underforsker:
          • Laura J Gray, PhD
        • Underforsker:
          • Harjeet S Rayt, MD
        • Underforsker:
          • Gregory S McMahon, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 110 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
12 month amputation rate
Tidsramme: 12 months post recruitment
Proportion of patients undergoing major lower limb amputation
12 months post recruitment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Amputation free survival
Tidsramme: ≥12 months post recruitment
Composite outcome measure of death or amputation
≥12 months post recruitment
All-cause mortality
Tidsramme: ≥12 months
Death from any cause
≥12 months
Quality of life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cognitive impairment (Frailty & Cognitive additional assessments only)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Baseline
Prevalence of coronary artery disease as detected by stress cardiac MRI
Baseline
Incidence of peri-operative myocardial infarction (Cardiac MR additional assessments only)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Leicester

Samarbejdspartnere

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

Efterforskere

  • Studiestol: Rob D Sayers, MD, University of Leicester

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. maj 2019

Primær færdiggørelse (Forventet)

9. maj 2022

Studieafslutning (Forventet)

9. maj 2031

Datoer for studieregistrering

Først indsendt

11. juli 2019

Først indsendt, der opfyldte QC-kriterier

18. juli 2019

Først opslået (Faktiske)

19. juli 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0686

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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