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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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