| NCT ID | NCT04027244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leicester |
| Condition | Peripheral Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 420 participants |
| Start Date | 2019-05-10 |
| Primary Completion | 2022-05-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 420 participants in total. It began in 2019-05-10 with a primary completion date of 2022-05-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Rob D Sayers, MD
STUDY CHAIR
University of Leicester
Frequently Asked Questions
Who can join the NCT04027244 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 110 Years, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04027244 currently recruiting?
Yes, NCT04027244 is actively recruiting participants. Contact the research team at rs152@le.ac.uk for enrollment information.
Where is the NCT04027244 trial being conducted?
This trial is being conducted at Leicester, United Kingdom.
Who is sponsoring the NCT04027244 clinical trial?
NCT04027244 is sponsored by University of Leicester. The principal investigator is Rob D Sayers, MD at University of Leicester. The trial plans to enroll 420 participants.