Chronic Limb-Threatening IschemiaNCT06404229
Use of CPETarm for Risk Stratification of Patients With CLTI
A study testing CardioPulmonary Exercise Testing in people with Chronic Limb-Threatening Ischemia and Surgery-Complications, run by University of Manchester at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Limb-Threatening Ischemia, Surgery-Complications
- What is being tested?
- CardioPulmonary Exercise Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 May 2024to 28 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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 join
- 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.
- Severe cardiac valvular stenosis
- Physical disability precluding ability to perform CPETarm
- Psychiatric disorder or dementia precluding them from consenting for research and/or undertaking testing and/or follow up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Manchester
Manchester, Greater Manchester, M13 9PL
Mr Jonathan Ghosh, Jonathan.Ghosh@manchester.ac.uk
Adam Haque, MBChB, PGCert, MSc, PhD, MRCS
About this study
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
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.
Read the detailed description
Chronic limb-threatening ischaemia (CLTI) is the most severe clinical manifestation of peripheral arterial disease, defined by the presence of pain at rest and/or tissue loss affecting the legs. It is a major cause of chronic pain, amputation and death. CLTI is a growing global healthcare problem attributable to the ageing population and increase of risk factors such such as diabetes.
Prevalence of high blood pressure, heart disease and diabetes is high amongst this cohort of patients and so it is unsurprising that surgery is associated with an alarmingly high risk of illness, complications and even death when compared to other types of surgery. As nearly half of the patients present as an emergency, assessment and optimisation of health prior to surgery is challenging.
The aims of the assessment prior to surgery includes optimising any current health problems, understanding what care may be required after surgery, allowing the patient to be fully informed of the risks and considering non surgical options where appropriate. Inadequate risk stratification can lead to delays in theatre, increased length of hospital stay and unnecessary loss of limb and/or life.
Currently there is no established method to risk stratify CLTI patients presenting as an emergency. CardioPulmonary Exercise Testing (CPET) is an exercise test useful in identification of a number of heart and lung conditions. The test is established for risk-stratification in other populations but its method of using a bicycle is not suitable for CLTI patients, nor has it previously been used in the emergency setting. This study will assess whether CPET using arm exercise instead of the traditional bicycle is a feasible test that can be performed at the bedside within 48 hours of intention to treat, required to make it a practical test in the assessment of emergency patients.
Hypothesis:
- Cardiopulmonary exercise testing using an arm ergometer (CPETarm) is a feasible, acceptable and safe tool to use at the 'bedside' in patients undergoing emergency surgery for chronic limb threatening ischaemia (CLTI).
- Values obtained from CPETarm and/or hand grip strength can be used to predict post operative outcomes including major adverse cardiovascular events and mortality for this group of patients.
Recruitment:
The study will enrol 120 consecutive, eligible and consenting patients admitted with with CLTI to the Manchester Vascular Centre at Manchester University National Health Service Foundation Trust. Patients scheduled to undergo non elective surgical or endovascular treatment of their chronic limb threatening ischaemia will be screened for inclusion. Decision for surgery/management will be recommended by their Consultant Vascular Surgeon.
- Being tested
- CardioPulmonary Exercise Testing
- Keywords
- CardioPulmonary Exercise Testing, Risk Stratification
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioPulmonary Exercise TestingDiagnostic test
CardioPulmonary Exercise Testing using an arm ergometer prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| CardioPulmonary Exercise Testing | Experimental | All patients included in the study will perform CardioPulmonary Exercise Testing prior to surgery Receives: Diagnostic Test: CardioPulmonary Exercise Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of bedside CPET
The percentage of recruited participants actually performing CPET compared to the number of patients consenting.
(A) identifying reasons, and their number, as to why participants did not undertake CPET, and (B) identifying reasons, and their number, for clinician-led termination of CPET
Measured: At time of CPET testing (1 day)
Recruitment rate (uptake of bedside CPET)
The percentage of eligible patients who gave informed consent to participate in the study
Measured: At time of CPET testing (1 day)
Practicality of bedside CPET
Recorded as three variables
- Time between decision for surgical intervention and CPET testing
- Location of testing
- Duration of testing (inclusive of set up, patient instructions, completion of test and recovery)
Measured: At time of CPET testing (1 day)
Patient reported outcome measures
Established by identifying participant opinions on satisfaction with, and suitability of, CPET for future use.
Assessed in a qualitative manner using a semi structured interview with 8 pre determined questions and quantitatively using a 5 point Likert scale for 12 statements, whereby 1='strongly disagree' and 5='strongly agree'.
Measured: 30 days
Adverse or unexpected events report
Defined as participants experiencing serious adverse events during or after the test.
Defined adverse events for CPET as: 1) death during the stress test, 2) external defibrillation or implantable cardioverter-defibrillator discharge, 3) sustained ventricular tachycardia (wide complex tachycardia lasting longer than 30 seconds), 4) myocardial infarction, 5) syncope, 6) administration of advanced cardiac life support medications, 7) referral for direct hospital admission, or 8) referral to emergency department
Measured: At time of CPET testing (1 day)
Secondary outcomes (11)
Peri-operative complications
Defined as defined as any complication that occurred during surgery or within 30 days of surgery. Graded using the Clavien-Dindo classification.
Measured: Recorded at 30 days
All cause mortality
Defined as death from any cause during the study
Measured: Recorded at 30 days, 90 days, 1 year, 3 years and 5 years
Amputation-free survival
Freedom of death and major limb amputation during the study
Measured: Recorded at 30 days, 90 days, 1 year, 3 years and 5 years
Level of care post-surgery
Categorised as according to the ward the patient is cared for in the immediate post operative period.
- Level 0 (postoperative recovery on a surgical ward
- Level 1 (postoperative recovery on a surgical ward with access to a critical care outreach team)
- Level 2 (high dependency unit, post anaesthesia care unit)
- Level 3 (intensive care unit)
Measured: Recorded at 30 days
Higher level of care length of stay
Recorded as the length of stay on a ward categorised as level 2 or 3.
Measured: Recorded at 30 days
Length of hospital stay
Defined as number of days spent in index hospital from date of operation.
Measured: Recorded at 30 days
Discharge destination
Recorded as place of discharge from hospital. Discharge destination, dichotomized as home or non-home. Non-home discharge was defined as discharge to a skilled care facility (e.g., a transitional care unit, subacute hospital, or skilled nursing home), unskilled care (e.g., nursing home or assisted facility, only if this was not the patient's preoperative location), separate acute care, rehabilitation, or a multi-level senior community)
Measured: Recorded at 30 days
Rate of re-intervention
Primary patency: Freedom from occlusion of bypass-graft or endovascular treated arterial segment and freedom of restenosis that need intervention in bypass-graft or endovascular treated arterial segment.
Secondary patency: Freedom from occlusion of bypass-graft or endovascular treated arterial segment. Treated for restenosis in bypass-graft or endovascular treated arterial segment.
Measured: Recorded at 30 day and 90 days
Hospital readmission rate
Defined as a readmission after discharge from the index hospital stay and within 90 days of the primary surgical procedure
Measured: Recorded at 30 and 90 days.
Health related quality of life
Health related quality of life measured by The Vascular Quality of Life Questionnaire 25 (VASCUQOL25). VascuQol consists of 25 items, subdivided into five domains. Each question has a seven-point response scale. The responses are averaged to give an overall and a domain score ranging from one (worst Health Related Quality of Life, HRQoL) to seven (best HRQoL).
Measured: Recorded at 30 and 90 days
Major adverse cardiovascular events
Defined as non fatal myocardial infarction, non fatal stroke, cardiovascular death, coronary intervention or unstable angina requiring hospitalisation.
Measured: Recorded at 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start28 May 2024 (estimated)
- Primary completion28 May 2025 (estimated)
- Study completion28 Apr 2030 (estimated)
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 Chronic Limb-Threatening IschemiaStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Ghosh, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404229
- Sponsor's protocol ID
- 329960
- Status last verified
- May 2024
- First submitted
- 12 Mar 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
[1] Conte MS, Bradbury AW, Kolh P, et al. GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. Eur J Vasc Endovasc Surg, 2019. 58: p. 1-109.
[2] Waton S, Johal A, Li Q, et al. National Vascular Registry: 2023 State of the Nation Report. London: The Royal College of Surgeons of England, November 2023.
Hodge S, Haque A, Quraishi-Akhtar T, Bryan A, Rogers S, Bowling FL, Ghosh J. Novel use of arm ergometry cardiopulmonary exercise testing for non-elective patients with chronic limb-threatening ischaemia: a feasibility trial. BMJ Open. 2026 Jun 15;16(6):e118841. doi: 10.1136/bmjopen-2026-118841.
PubMed 42297459
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06404229
- Acronym / sponsor ID
- 329960
- Keywords
- CardioPulmonary Exercise Testing, Risk Stratification
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 28 May 2024 (estimated)
- Primary completion
- 28 May 2025 (estimated)
- Study completion
- 28 Apr 2030 (estimated)
- First posted
- 8 May 2024 (actual)
- 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.
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.
Detailed description
Chronic limb-threatening ischaemia (CLTI) is the most severe clinical manifestation of peripheral arterial disease, defined by the presence of pain at rest and/or tissue loss affecting the legs. It is a major cause of chronic pain, amputation and death. CLTI is a growing global healthcare problem attributable to the ageing population and increase of risk factors such such as diabetes.
Prevalence of high blood pressure, heart disease and diabetes is high amongst this cohort of patients and so it is unsurprising that surgery is associated with an alarmingly high risk of illness, complications and even death when compared to other types of surgery. As nearly half of the patients present as an emergency, assessment and optimisation of health prior to surgery is challenging.
The aims of the assessment prior to surgery includes optimising any current health problems, understanding what care may be required after surgery, allowing the patient to be fully informed of the risks and considering non surgical options where appropriate. Inadequate risk stratification can lead to delays in theatre, increased length of hospital stay and unnecessary loss of limb and/or life.
Currently there is no established method to risk stratify CLTI patients presenting as an emergency. CardioPulmonary Exercise Testing (CPET) is an exercise test useful in identification of a number of heart and lung conditions. The test is established for risk-stratification in other populations but its method of using a bicycle is not suitable for CLTI patients, nor has it previously been used in the emergency setting. This study will assess whether CPET using arm exercise instead of the traditional bicycle is a feasible test that can be performed at the bedside within 48 hours of intention to treat, required to make it a practical test in the assessment of emergency patients.
Hypothesis:
- Cardiopulmonary exercise testing using an arm ergometer (CPETarm) is a feasible, acceptable and safe tool to use at the 'bedside' in patients undergoing emergency surgery for chronic limb threatening ischaemia (CLTI).
- Values obtained from CPETarm and/or hand grip strength can be used to predict post operative outcomes including major adverse cardiovascular events and mortality for this group of patients.
Recruitment:
The study will enrol 120 consecutive, eligible and consenting patients admitted with with CLTI to the Manchester Vascular Centre at Manchester University National Health Service Foundation Trust. Patients scheduled to undergo non elective surgical or endovascular treatment of their chronic limb threatening ischaemia will be screened for inclusion. Decision for surgery/management will be recommended by their Consultant Vascular Surgeon.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CardioPulmonary Exercise Testing | Experimental | Diagnostic Test: CardioPulmonary Exercise TestingAll patients included in the study will perform CardioPulmonary Exercise Testing prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
- Severe cardiac valvular stenosis
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 |
|---|---|---|
| CardioPulmonary Exercise TestingCardioPulmonary Exercise Testing using an arm ergometer prior to surgery | Diagnostic test | CardioPulmonary Exercise Testing |
Primary outcome
Acceptability of bedside CPET
Time frame: At time of CPET testing (1 day)
The percentage of recruited participants actually performing CPET compared to the number of patients consenting. (A) identifying reasons, and their number, as to why participants did not undertake CPET, and (B) identifying reasons, and their number, for clinician-led termination of CPET
Recruitment rate (uptake of bedside CPET)
Time frame: At time of CPET testing (1 day)
The percentage of eligible patients who gave informed consent to participate in the study
Practicality of bedside CPET
Time frame: At time of CPET testing (1 day)
Recorded as three variables 1. Time between decision for surgical intervention and CPET testing 2. Location of testing 3. Duration of testing (inclusive of set up, patient instructions, completion of test and recovery)
Patient reported outcome measures
Time frame: 30 days
Established by identifying participant opinions on satisfaction with, and suitability of, CPET for future use. Assessed in a qualitative manner using a semi structured interview with 8 pre determined questions and quantitatively using a 5 point Likert scale for 12 statements, whereby 1='strongly disagree' and 5='strongly agree'.
Adverse or unexpected events report
Time frame: At time of CPET testing (1 day)
Defined as participants experiencing serious adverse events during or after the test. Defined adverse events for CPET as: 1) death during the stress test, 2) external defibrillation or implantable cardioverter-defibrillator discharge, 3) sustained ventricular tachycardia (wide complex tachycardia lasting longer than 30 seconds), 4) myocardial infarction, 5) syncope, 6) administration of advanced cardiac life support medications, 7) referral for direct hospital admission, or 8) referral to emergency department
11 secondary outcomes
Peri-operative complications
Time frame: Recorded at 30 days
All cause mortality
Time frame: Recorded at 30 days, 90 days, 1 year, 3 years and 5 years
Amputation-free survival
Time frame: Recorded at 30 days, 90 days, 1 year, 3 years and 5 years
Level of care post-surgery
Time frame: Recorded at 30 days
Higher level of care length of stay
Time frame: Recorded at 30 days
Length of hospital stay
Time frame: Recorded at 30 days
Discharge destination
Time frame: Recorded at 30 days
Rate of re-intervention
Time frame: Recorded at 30 day and 90 days
Hospital readmission rate
Time frame: Recorded at 30 and 90 days.
Health related quality of life
Time frame: Recorded at 30 and 90 days
Major adverse cardiovascular events
Time frame: Recorded at 30 and 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background[1] Conte MS, Bradbury AW, Kolh P, et al. GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. Eur J Vasc Endovasc Surg, 2019. 58: p. 1-109.
- Background[2] Waton S, Johal A, Li Q, et al. National Vascular Registry: 2023 State of the Nation Report. London: The Royal College of Surgeons of England, November 2023.
- Derived from this study: PubMed 42297459Hodge S, Haque A, Quraishi-Akhtar T, Bryan A, Rogers S, Bowling FL, Ghosh J. Novel use of arm ergometry cardiopulmonary exercise testing for non-elective patients with chronic limb-threatening ischaemia: a feasibility trial. BMJ Open. 2026 Jun 15;16(6):e118841. doi: 10.1136/bmjopen-2026-118841.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioPulmonary Exercise Testing in people with Chronic Limb-Threatening Ischemia and Surgery-Complications, run by University of Manchester 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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 May 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of bedside CPET (time frame: At time of CPET testing (1 day)). The study lists 5 primary outcomes in all. 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 NCT06404229, 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 8 May 2024.