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Cardiopulmonary Exercise Test in Peripheral Arterial Disease

Not Applicable
Completed
Conditions
Peripheral Arterial Disease
Interventions
Procedure: Arterial Revascularization surgery or Endovascular procedure
Registration Number
NCT02657278
Lead Sponsor
Liverpool University Hospitals NHS Foundation Trust
Brief Summary

Aim: To determine whether the lactate threshold during CPET is influenced by the presence of haemodynamically significant PAD.

Assumption: Correction of haemodynamically significant PAD results in an increased LT, measured by CPET.

Design: Prospective study Population: Thirty patients scheduled to undergo surgical or percutaneous treatment of iliofemoral arterial disease for intermittent claudication.

Detailed Description

Patients scheduled to undergo surgery or angioplasty of the iliofemoral segment for intermittent claudication will be screened for inclusion. Consenting patients will undergo ABI measurements and CPET before treatment and four weeks after treatment. Study measures will be performed in the respiratory physiology laboratory at University Hospital Aintree. Demographic and medical details will be recorded including gender, age, smoking history and pack years, medical history and treatment and BMI. A record will be made of patuients' latest full blood count which will be routinely available in all participants before the procedure. Ankle-brachial index will be recorded. The subjects will undergo full CPET. This includes recording of baseline spirometry, full ECG monitoring throughout the test, measurement of ventilator parameters and recording of Borg breathlessness and leg fatigue score every minute. At the end of the test the reason for cessation will be documented. The test will be incremental with a 10-20W ramp determined according to baseline MVV aiming for the subject to exercise for 10-12 minutes. The test will involve 3 minutes rest, 2 minutes free-pedal followed by continuous ramping until volition. Recording will continue for 5 minutes recovery

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
31
Inclusion Criteria
  • Written informed consent, ability to perform a CPET on a cycle ergometer, intermittent claudication as presenting complaint, age ≥18, iliofemoral arterial disease
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Exclusion Criteria
  • Critical limb ischaemia, unwillingness to consent, previous amputation or other inability to perform CPET on a cycle ergometer, age <18, absence of iliofemoral arterial disease, any standard CPET exclusion based on American Thoracic Society/European Respiratory Society Guidelines, including severe arthritis or lower limb abnormality precluding exercise testing, severe hypertension at rest, unstable angina or acute coronary syndrome within the previous 6 weeks, terminal illness/advanced cancer or major psychiatric illness, including dementia, which precludes consent
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Symptomatic Peripheral arterial diseaseArterial Revascularization surgery or Endovascular procedurePatients scheduled to undergo surgery or angioplasty of the iliofemoral segment for intermittent claudication.
Primary Outcome Measures
NameTimeMethod
The difference in Lactate Threshold (LT) between the two CPETsFour weeks following the intervention
Secondary Outcome Measures
NameTimeMethod
The correlation between rise in LT post treatment (if any) and haemodynamic measures of PAD improvement (ankle-brachial index - ABI - differential).Four weeks following the intervention
The effect of the intervention on peak oxygen delivery during exercise.Four weeks following the intervention

Trial Locations

Locations (1)

Liverpool Vascular & Endovascular Service and Department of Respiratory Medicine, Aintree University Hospitals NHS Foundation Trust

🇬🇧

Liverpool, United Kingdom

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