Clinical trial NCT06404229: Use of CPETarm for Risk Stratification of Patients With CLTI
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Limb-Threatening Ischemia
Surgery-Complications
Keywords: CardioPulmonary Exercise Testing
Risk Stratification
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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:

1. 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).
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acceptability of bedside CPET
timeFrame: At time of CPET testing (1 day)
measure: Recruitment rate (uptake of bedside CPET)
timeFrame: At time of CPET testing (1 day)
measure: Practicality of bedside CPET
timeFrame: At time of CPET testing (1 day)
measure: Patient reported outcome measures
timeFrame: 30 days
measure: Adverse or unexpected events report
timeFrame: At time of CPET testing (1 day)
Secondary outcomes:
measure: Peri-operative complications
timeFrame: Recorded at 30 days
measure: All cause mortality
timeFrame: Recorded at 30 days, 90 days, 1 year, 3 years and 5 years
measure: Amputation-free survival
timeFrame: Recorded at 30 days, 90 days, 1 year, 3 years and 5 years
measure: Level of care post-surgery
timeFrame: Recorded at 30 days
measure: Higher level of care length of stay
timeFrame: Recorded at 30 days
measure: Length of hospital stay
timeFrame: Recorded at 30 days
measure: Discharge destination
timeFrame: Recorded at 30 days
measure: Rate of re-intervention
timeFrame: Recorded at 30 day and 90 days
measure: Hospital readmission rate
timeFrame: Recorded at 30 and 90 days.
measure: Health related quality of life
timeFrame: Recorded at 30 and 90 days
measure: Major adverse cardiovascular events
timeFrame: Recorded at 30 and 90 days
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester
state: Greater Manchester
Study officials:
References:
citation: [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.
citation: [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.