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Cardiopulmonary Exercise Test in Peripheral Arterial Disease

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Arterial Revascularization surgery or Endovascular procedure
Sponsored by
Liverpool University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Peripheral Arterial Disease focused on measuring Peripheral arterial disease,, Cardipulmonary Exercise Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Liverpool Vascular & Endovascular Service and Department of Respiratory Medicine, Aintree University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Symptomatic Peripheral arterial disease

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The correlation between rise in LT post treatment (if any) and haemodynamic measures of PAD improvement (ankle-brachial index - ABI - differential).
The effect of the intervention on peak oxygen delivery during exercise.

Full Information

First Posted
January 13, 2016
Last Updated
January 10, 2018
Sponsor
Liverpool University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02657278
Brief Title
Cardiopulmonary Exercise Test in Peripheral Arterial Disease
Official Title
The Influence of Peripheral Arterial Disease (PAD) on the Onset of Lactate Threshold (LT) in Patients Undergoing Cardiopulmonary Exercise Test (CPET)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liverpool University Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral arterial disease,, Cardipulmonary Exercise Test

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symptomatic Peripheral arterial disease
Arm Type
Other
Arm Description
Patients scheduled to undergo surgery or angioplasty of the iliofemoral segment for intermittent claudication.
Intervention Type
Procedure
Intervention Name(s)
Arterial Revascularization surgery or Endovascular procedure
Intervention Description
Symptoms limited Cardiopulmonary Exercise Test (CPET) performed before and four weeks after surgical or endovascular correction of peripheral arterial disease
Primary Outcome Measure Information:
Title
The difference in Lactate Threshold (LT) between the two CPETs
Time Frame
Four weeks following the intervention
Secondary Outcome Measure Information:
Title
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
Title
The effect of the intervention on peak oxygen delivery during exercise.
Time Frame
Four weeks following the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Torella
Organizational Affiliation
Aintree University Hospital Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liverpool Vascular & Endovascular Service and Department of Respiratory Medicine, Aintree University Hospitals NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22521839
Citation
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.
Results Reference
background
PubMed Identifier
33818006
Citation
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.
Results Reference
derived
PubMed Identifier
27993904
Citation
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.
Results Reference
derived

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Cardiopulmonary Exercise Test in Peripheral Arterial Disease

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