Peripheral Artery DiseaseExercisePADNCT03186391
Exercise Testing in Peripheral Artery Disease Patients
An observational study of Peripheral Artery Disease, run by Rennes University Hospital at 1 site in France.
Trial summary
The aim of this study was to evaluate exercise testing in case of patients suspected of Peripheral Artery Disease (PAD). Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Data collected
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2014to 31 Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred to our vascular unit with exercise limitation
Who may be able to join
- All patients addressed in our vascular unit for exercise limitation
Who cannot join
- Incapacity to walk on the treadmill.
- A severe cardiopathy contraindicating a stress test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre hospitalier Universitaire
Rennes, 35033
Mahé Guillaume, 299284261 ext. +33, guillaume.mahe@chu-rennes.fr
About this study
Official title: 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).
Read the 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Data collected
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectedOther
Use the data collected during a usual consultation to study the relationship between different parameters (rest pressure ...) and imaging
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected PAD | Use the data collected during a usual consultation to study the relationship between different parameters (rest pressure ...) and imaging Receives: Other: Data collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-min Post-exercise Ankle-Brachial Index (ABI)
Post exercise pressures at 1 minute after the stop of walking on each ankle and arm.
Measured: at 1 minute after the stop of walking
Secondary outcomes (2)
3-min Post-exercise Ankle-Brachial Index (ABI)
Post exercise pressures at 3 minutes after the stop of walking on each ankle and arm.
Measured: at 3 minutes after the stop of walking
5-min Post-exercise Ankle-Brachial Index (ABI)
Post exercise pressures at 5 minutes after the stop of walking on each ankle and arm.
Measured: at 5 minutes after the stop of walking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start24 Feb 2014
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahé Guillaume, MD-PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186391
- Sponsor's protocol ID
- 35RC17_3064
- Acronym
- ExercisePAD
- Status last verified
- Mar 2025
- First submitted
- 23 May 2017
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vannier C, Guezais A, Talbot M, Le Faucheur A, Mahe G. Relationship between exercise transcutaneous oxygen pressure measurements with constant and graded treadmill tests. Vasc Med. 2025 Dec;30(6):676-682. doi: 10.1177/1358863X251379810. Epub 2025 Nov 5.
PubMed 41193436Metairie A, Tollenaere Q, Laneelle D, Le Faucheur A, Le Pabic E, Omarjee L, Mahe G. Simplification of ankle-brachial-index measurement using Doppler-waveform classification in symptomatic patients suspected of lower extremity artery disease. Front Cardiovasc Med. 2022 Sep 9;9:941600. doi: 10.3389/fcvm.2022.941600. eCollection 2022.
PubMed 36158813