Peripheral Arterial DiseaseNCT02657278
Cardiopulmonary Exercise Test in Peripheral Arterial Disease
A study testing Arterial Revascularization surgery or Endovascular procedure in people with Peripheral Arterial Disease, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Arterial Revascularization surgery or Endovascular procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent, ability to perform a CPET on a cycle ergometer, intermittent claudication as presenting complaint, age ≥18, iliofemoral arterial disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Vascular & Endovascular Service and Department of Respiratory Medicine, Aintree University Hospitals NHS Foundation Trust
Liverpool, L9 7AL
About this study
Official title: The Influence of Peripheral Arterial Disease (PAD) on the Onset of Lactate Threshold (LT) in Patients Undergoing Cardiopulmonary Exercise Test (CPET)
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
- Conditions
- Peripheral Arterial Disease
- Being tested
- Arterial Revascularization surgery or Endovascular procedure
- Keywords
- Peripheral arterial disease,, Cardipulmonary Exercise Test
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Revascularization surgery or Endovascular procedureProcedure or surgery
Symptoms limited Cardiopulmonary Exercise Test (CPET) performed before and four weeks after surgical or endovascular correction of peripheral arterial disease
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic Peripheral arterial disease | Other | Patients scheduled to undergo surgery or angioplasty of the iliofemoral segment for intermittent claudication. Receives: Procedure: Arterial Revascularization surgery or Endovascular procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in Lactate Threshold (LT) between the two CPETs
Measured: Four weeks following the intervention
Secondary outcomes (2)
The correlation between rise in LT post treatment (if any) and haemodynamic measures of PAD improvement (ankle-brachial index - ABI - differential).
Measured: Four weeks following the intervention
The effect of the intervention on peak oxygen delivery during exercise.
Measured: Four weeks following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Francesco Torella, Liverpool University Hospitals NHS Foundation Trust
- Investigators
- Francesco Torella, Principal investigator, Aintree University Hospital Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657278
- Sponsor's protocol ID
- 825/15
- Status last verified
- Jan 2018
- First submitted
- 13 Jan 2016
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 22521839Barkat 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 33818006Key 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Peripheral Arterial Disease (PAD) on the Onset of Lactate Threshold (LT) in Patients Undergoing Cardiopulmonary Exercise Test (CPET)
- ClinicalTrials.gov ID
- NCT02657278
- Acronym / sponsor ID
- 825/15
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral arterial disease,, Cardipulmonary Exercise Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- Jan 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic Peripheral arterial disease | Other | Procedure: Arterial Revascularization surgery or Endovascular procedurePatients scheduled to undergo surgery or angioplasty of the iliofemoral segment for intermittent claudication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Written informed consent, ability to perform a CPET on a cycle ergometer, intermittent claudication as presenting complaint, age ≥18, iliofemoral arterial disease
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial Revascularization surgery or Endovascular procedureSymptoms limited Cardiopulmonary Exercise Test (CPET) performed before and four weeks after surgical or endovascular correction of peripheral arterial disease | Procedure or surgery | Symptomatic Peripheral arterial disease |
Primary outcome
The difference in Lactate Threshold (LT) between the two CPETs
Time frame: Four weeks following the intervention
2 secondary outcomes
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
The effect of the intervention on peak oxygen delivery during exercise.
Time frame: Four weeks following the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Background: PubMed 22521839Young 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.
- Derived from this study: PubMed 33818006Barkat 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.
- Derived from this study: PubMed 27993904Key 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Torella principal investigator
Aintree University Hospital Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial Revascularization surgery or Endovascular procedure in people with Peripheral Arterial Disease, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in Lactate Threshold (LT) between the two CPETs (time frame: Four weeks following the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657278, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.