NCT04027244Recruiting
Leg Ischaemia Management Collaboration
Source: ClinicalTrials.gov · Last updated 4 Nov 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 420 (estimated)
- First submitted
- 11 Jul 2019
- Start date
- 10 May 2019
- Primary completion date
- 9 May 2022
- Lead sponsor
- University of Leicester
- Diseases
- Coronary artery disease
- NCT number
- NCT04027244
What you commit to
- Study type: Observational
- Planned participants: 420
- From 10 May 2019 to the primary completion date, 9 May 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing intervention during their index presentation prior to recruitment
Other illness
- 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
- Nil additional
- CARDIAC MRI ADDITIONAL ASSESSMENTS
- 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)
- Patients lacking capacity to consent for cardiac MRI
- BIOMARKERS ADDITIONAL ASSESSMENTS
Lab values
- Contraindication to gadolinium contrast agent (Known adverse reaction, chronic renal failure (eGFR \<30mL/min/1.73m\^2))
Other
- SLI not caused by PAOD
- 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
- Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention
- Nil additional
Who the study is looking for
- All patients presenting to the Leicester Vascular Institute with SLI
- Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention for SLI
- Patients aged ≥65 years
- Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention
Criteria the registry did not label
- PRIMARY COHORT
Age in the registry: 18 years to 110 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Glenfield Hospital Leicester Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.