NCT02657278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

January 13, 2016

Last Update Submit

January 10, 2018

Conditions

Peripheral Arterial Disease

Keywords

Peripheral arterial disease,Cardipulmonary Exercise Test

Outcome Measures

Primary Outcomes (1)

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

    Four weeks following the intervention

Secondary Outcomes (2)

  • The correlation between rise in LT post treatment (if any) and haemodynamic measures of PAD improvement (ankle-brachial index - ABI - differential).

    Four weeks following the intervention

  • The effect of the intervention on peak oxygen delivery during exercise.

    Four weeks following the intervention

Study Arms (1)

Symptomatic Peripheral arterial disease

OTHER

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

Procedure: Arterial Revascularization surgery or Endovascular procedure

Interventions

Arterial Revascularization surgery or Endovascular procedurePROCEDURE

Symptoms limited Cardiopulmonary Exercise Test (CPET) performed before and four weeks after surgical or endovascular correction of peripheral arterial disease

Symptomatic Peripheral arterial disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent, ability to perform a CPET on a cycle ergometer, intermittent claudication as presenting complaint, age ≥18, iliofemoral arterial disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Liverpool, L9 7AL, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 22521839BACKGROUND

  • 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.

    PMID: 33818006DERIVED

  • 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.

    PMID: 27993904DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Endovascular Procedures

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Francesco Torella

    Aintree University Hospital Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Vascular Surgeon

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 15, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

January 12, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)