Use of CPETarm for Risk Stratification of Patients With CLTI
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manchester
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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 arrthymic requiring the initiation or up titration of an anti arrthymic medication
Active congestive cardiac failure requiring the initiation or up titration of diuretic therapy.
Trial design
Treatments tested in this trial
- CardioPulmonary Exercise Testing
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov