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Cardiopulmonary Exercise Test in Peripheral Arterial Disease

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ClinicalTrials.gov Identifier: NCT02657278
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Francesco Torella, Aintree University Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Procedure: Arterial Revascularization surgery or Endovascular procedure Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Influence of Peripheral Arterial Disease (PAD) on the Onset of Lactate Threshold (LT) in Patients Undergoing Cardiopulmonary Exercise Test (CPET)
Actual Study Start Date : January 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Symptomatic Peripheral arterial disease
Patients scheduled to undergo surgery or angioplasty of the iliofemoral segment for intermittent claudication.
Procedure: Arterial Revascularization surgery or Endovascular procedure
Symptoms limited Cardiopulmonary Exercise Test (CPET) performed before and four weeks after surgical or endovascular correction of peripheral arterial disease




Primary Outcome Measures :
  1. The difference in Lactate Threshold (LT) between the two CPETs [ Time Frame: Four weeks following the intervention ]

Secondary Outcome Measures :
  1. 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 ]
  2. The effect of the intervention on peak oxygen delivery during exercise. [ Time Frame: Four weeks following the intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657278


Locations
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United Kingdom
Liverpool Vascular & Endovascular Service and Department of Respiratory Medicine, Aintree University Hospitals NHS Foundation Trust
Liverpool, United Kingdom, L9 7AL
Sponsors and Collaborators
Aintree University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Francesco Torella Aintree University Hospital Foundation Trust

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francesco Torella, Consultant Vascular Surgeon, Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02657278     History of Changes
Other Study ID Numbers: 825/15
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Francesco Torella, Aintree University Hospitals NHS Foundation Trust:
Peripheral arterial disease,
Cardipulmonary Exercise Test

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases