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CompletedNCT02657278Updated Jan 12, 2018

Cardiopulmonary Exercise Test in Peripheral Arterial Disease

An interventional study of Arterial Revascularization surgery or Endovascular procedure in Peripheral Arterial Disease, sponsored by Liverpool University Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-12.

Sponsored by Liverpool University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Peripheral Arterial Disease

Keywords

  • Peripheral arterial disease,
  • Cardipulmonary Exercise Test
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 31 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Liverpool University Hospitals NHS Foundation Trust is the lead sponsor of 60 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Written informed consent, ability to perform a CPET on a cycle ergometer, intermittent claudication as presenting complaint, age ≥18, iliofemoral arterial disease

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Other
    Symptomatic Peripheral arterial disease

    Patients scheduled to undergo surgery or angioplasty of the iliofemoral segment for intermittent claudication.

    Procedure: Arterial Revascularization surgery or Endovascular procedure

Interventions

  • ProcedureArterial Revascularization surgery or Endovascular procedure

    Symptoms limited Cardiopulmonary Exercise Test (CPET) performed before and four weeks after surgical or endovascular correction of peripheral arterial disease

06

What researchers measure

Primary outcomes

  1. The difference in Lactate Threshold (LT) between the two CPETs

    Time frame: Four weeks following the intervention

Secondary outcomes

  1. The correlation between rise in LT post treatment (if any) and haemodynamic measures of PAD improvement (ankle-brachial index - ABI - differential).

    Time frame: Four weeks following the intervention

  2. The effect of the intervention on peak oxygen delivery during exercise.

    Time frame: Four weeks following the intervention

07

Study locations

1 site
  • Liverpool Vascular & Endovascular Service and Department of Respiratory Medicine, Aintree University Hospitals NHS Foundation Trust
    Liverpool, L9 7AL, United Kingdom
08

References and documents

Publications

  • Young EL, Karthikesalingam A, Huddart S, Pearse RM, Hinchliffe RJ, Loftus IM, Thompson MM, Holt PJ. A systematic review of the role of cardiopulmonary exercise testing in vascular surgery. Eur J Vasc Endovasc Surg. 2012 Jul;44(1):64-71. doi: 10.1016/j.ejvs.2012.03.022. Epub 2012 Apr 21. PubMed 22521839 ↗
  • Barkat M, Key A, Ali T, Walker P, Duffy N, Snellgrove J, Torella F. Effect of treatment of peripheral arterial disease on the onset of anaerobic exercise during cardiopulmonary exercise testing. Physiol Rep. 2021 Apr;9(7):e14815. doi: 10.14814/phy2.14815. PubMed 33818006 ↗
  • Key A, Ali T, Walker P, Duffy N, Barkat M, Snellgrove J, Torella F. Effect of peripheral arterial disease on the onset of lactate threshold during cardiopulmonary exercise test: study protocol. BMJ Open. 2016 Dec 19;6(12):e012763. doi: 10.1136/bmjopen-2016-012763. PubMed 27993904 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02657278
Lead sponsor
Liverpool University Hospitals NHS Foundation Trust
Responsible party
Francesco Torella (Consultant Vascular Surgeon, Liverpool University Hospitals NHS Foundation Trust) — Principal investigator
First posted
Jan 15, 2016
Start date
Jan 2016
Primary completion
Apr 2017
Completion
Apr 2017
Last update
Jan 12, 2018

Study contacts

Francesco Torella
principal investigator · Aintree University Hospital Foundation Trust

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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