Not yet taking people in United KingdomNo phase
Use of CPETarm for Risk Stratification of Patients With CLTI
Key facts
- Who runs it
- University of Manchester
- Where
- Manchester, United KingdomSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 120 people, planned
- Started
- 28 May 2024
- Expected to end
- 28 Apr 2030
- Type of study
- Interventional
- Treatments tested
- CardioPulmonary Exercise Testing
- Record updated
- 8 May 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Ability and willingness to give written informed consent
- Diagnosis of chronic limb threatening ischaemia, undergoing one of the following procedures: Infra inguinal bypass, Extra anatomical bypass, Common femoral endarterectomy, Endovascular treatment, Primary amputation
Who cannot take part
- Active arrthymic requiring the initiation or up titration of an anti arrthymic medication
- Patients with active medical conditions deemed an absolute contraindication for undertaking CPET
- Ongoing evaluation for coronary artery disease (e.g awaiting stress test or cardiac catheterisation or requiring the up titration of anti anginal medications)
- Active congestive cardiac failure requiring the initiation or up titration of diuretic therapy
- Severe cardiac valvular stenosis
- Psychiatric disorder or dementia precluding them from consenting for research and/or undertaking testing and/or follow up
- Physical disability precluding ability to perform CPETarm
Where in United Kingdom
- University of ManchesterManchester, United KingdomContact: Mr Jonathan GhoshNo longer taking part
About the trial
What the trial wants to find out
This is a prospective cohort study of patients undergoing surgery for chronic limb threatening ischaemia. Prior to surgery, patients will undergo CardioPulmonary Exercise testing (CPET) using an arm ergometer. Feasibility outcome measures will be recorded at testing and participants will be followed up for a period of up to 5 years to obtain clinical outcome measures.
The group in the trial
- CardioPulmonary Exercise TestingTreatment being tested
All patients included in the study will perform CardioPulmonary Exercise Testing prior to surgery
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Novel Use of Bedside Arm Ergometry CardioPulmonary Exercise Tests for the Risk Stratification of Patients With Chronic Limb-threatening Ischaemia: A Feasibility Trial
- Publications
- Record updated
- 8 May 2024