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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of the AHA Post-exercise ABI Criteria
- ClinicalTrials.gov ID
- NCT03186391
- Acronym / sponsor ID
- ExercisePAD / 35RC17_3064
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 24 Feb 2014 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate exercise testing in case of patients suspected of Peripheral Artery Disease (PAD).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected PAD | – | Other: Data collectedUse the data collected during a usual consultation to study the relationship between different parameters (rest pressure ...) and imaging |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred to our vascular unit with exercise limitation
Key inclusion criteria (1 listed)
- All patients addressed in our vascular unit for exercise limitation
Key exclusion criteria (2 listed)
- Incapacity to walk on the treadmill.
- A severe cardiopathy contraindicating a stress test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectedUse the data collected during a usual consultation to study the relationship between different parameters (rest pressure ...) and imaging | Other | Patients with suspected PAD |
Primary outcome
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.
2 secondary outcomes
3-min Post-exercise Ankle-Brachial Index (ABI)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Derived from this study: PubMed 41193436Vannier 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.
- Derived from this study: PubMed 36158813Metairie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahé Guillaume, MD-PhD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahé Guillaume, MD-PhD (2 99 28 42 61 ext. +33, guillaume.mahe@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-min Post-exercise Ankle-Brachial Index (ABI) (time frame: at 1 minute after the stop of walking). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03186391, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.