Exercise Testing in Peripheral Artery Disease Patients (ExercisePAD)

March 10, 2025 updated by: Rennes University Hospital

Sensitivity and Specificity of the AHA Post-exercise ABI Criteria

The aim of this study was to evaluate exercise testing in case of patients suspected of Peripheral Artery Disease (PAD).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a non interventional prospective cross sectional, monocentric study. All patients addressed in our vascular unit for exercise testing were included. All patients' data performed in clinical routine can be analyzed.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients referred to our vascular unit with exercise limitation

Description

Inclusion Criteria:

  • All patients addressed in our vascular unit for exercise limitation

Exclusion Criteria:

  • Incapacity to walk on the treadmill.
  • A severe cardiopathy contraindicating a stress test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with suspected PAD
Use the data collected during a usual consultation to study the relationship between different parameters (rest pressure ...) and imaging
Other: Data collected
Use the data collected during a usual consultation to study the relationship between different parameters (rest pressure ...) and imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-min Post-exercise Ankle-Brachial Index (ABI)
Time Frame: at 1 minute after the stop of walking
Post exercise pressures at 1 minute after the stop of walking on each ankle and arm.
at 1 minute after the stop of walking

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-min Post-exercise Ankle-Brachial Index (ABI)
Time Frame: at 3 minutes after the stop of walking
Post exercise pressures at 3 minutes after the stop of walking on each ankle and arm.
at 3 minutes after the stop of walking
5-min Post-exercise Ankle-Brachial Index (ABI)
Time Frame: at 5 minutes after the stop of walking
Post exercise pressures at 5 minutes after the stop of walking on each ankle and arm.
at 5 minutes after the stop of walking

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Mahé Guillaume, MD-PhD, Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2014

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

June 12, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC17_3064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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