Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404229
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-12
Brief Title:
Use of CPETarm for Risk Stratification of Patients With CLTI
Sponsor:
University of Manchester
Organization:
University of Manchester
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor 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 andor 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 surgerymanagement will be recommended by their Consultant Vascular Surgeon
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 andor 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 andor 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 surgerymanagement will be recommended by their Consultant Vascular Surgeon
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None