Peripheral Artery Disease (PAD)NCT06701032
Hemodynamic Parameters in People With Atherosclerotic Vascular Disease Referred to a Secondary Prevention and Cardiovascular Rehabilitation Program
A study testing Cardiovascular rehabilitation program in people with Peripheral Artery Disease (PAD) and Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by Laval University at 1 site in Canada.
Trial summary
The main purpose of this study is to evaluate the hemodynamic changes in the forefoot of patients with coronary, cerebrovascular or peripheral atherosclerotic disease referred a 12-week cardiovascular rehabilitation program (PREV program). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease (PAD), Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Cerebrovascular Atherosclerosis
- What is being tested?
- Cardiovascular rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 25 Nov 2024to Sep 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any individual aged 18 years and older who has been diagnosed with peripheral artery disease, coronary artery disease, angina, ischemic heart failure, transient ischemic attack or ischemic stroke (non-cardioembolic, non-hemorrhagic);
- Have been admitted to the PREV program;
Who cannot join
- Being not able to give written informed consent;
Trial locations and contacts
1 site in 1 country.
Canada1 site
CLSC de Lévis - Programme PREV du CISSS de Chaudière-Appalaches
Lévis, Quebec, G6V 0M4
About this study
Official title: Evolution of Hemodynamic Parameters in People With Atherosclerotic Vascular Disease Referred to a Secondary Prevention and Cardiovascular Rehabilitation (PREV) Program: a Prospective Cohort Study.
The main purpose of this study is to evaluate the hemodynamic changes in the forefoot of patients with coronary, cerebrovascular or peripheral atherosclerotic disease referred a 12-week cardiovascular rehabilitation program (PREV program).
Also, this study will describe the characteristics of patients admitted to the PREV program and their evolutions in terms of favorable, unfavorable outcomes and complications and up to one year after completion of the program.
- Conditions
- Peripheral Artery Disease (PAD), Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Cerebrovascular Atherosclerosis
- Being tested
- Cardiovascular rehabilitation program
- Keywords
- cardiovascular rehabilitation, supervised exercise therapy, secondary prevention, cardiovascular secondary prevention, cardiovascular rehabilitation program, hemodynamics of lower limbs, toe pressure measurement
- Medical subject headings
- Peripheral Arterial Disease, Coronary Artery Disease, Angina Pectoris, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular rehabilitation programOther
The cardiovascular rehabilitation program consists of a 12 weeks supervised exercises therapy (either in person or in tele-care)
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular rehabilitation program | Experimental | Not described Receives: Other: Cardiovascular rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in toe pressure measurement
Results will be measured in mm Hg
Measured: Change from baseline to 12 weeks
Change in the toe-brachial index
Measured: Change from baseline to 12 weeks
Change in the ankle-brachial index
Measured: Change from baseline to 12 weeks
Secondary outcomes (2)
Change in 6-minute walk test (6MWT)
Results will be measured in meters
Measured: Change from Baseline to 12 weeks
Short Form Health Survey 36 (SF-36)
Change in quality of life measured using the SF-36 questionnaire. The scores range from 0-100.
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start25 Nov 2024
- Primary completion29 Aug 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease (PAD)Studies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- CISSS de Chaudière-Appalaches
- Responsible party
- Principal investigator, Jérôme Patry, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701032
- Sponsor's protocol ID
- CISSSCA-2025-1208
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Hemodynamic Parameters in People With Atherosclerotic Vascular Disease Referred to a Secondary Prevention and Cardiovascular Rehabilitation (PREV) Program: a Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT06701032
- Acronym / sponsor ID
- CISSSCA-2025-1208
- Conditions
- Peripheral Artery Disease (PAD), Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Cerebrovascular Atherosclerosis
- Keywords
- cardiovascular rehabilitation, supervised exercise therapy, secondary prevention, cardiovascular secondary prevention, cardiovascular rehabilitation program, hemodynamics of lower limbs, toe pressure measurement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- CISSS de Chaudière-Appalaches
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Nov 2024 (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 main purpose of this study is to evaluate the hemodynamic changes in the forefoot of patients with coronary, cerebrovascular or peripheral atherosclerotic disease referred a 12-week cardiovascular rehabilitation program (PREV program).
Also, this study will describe the characteristics of patients admitted to the PREV program and their evolutions in terms of favorable, unfavorable outcomes and complications and up to one year after completion of the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular rehabilitation program | Experimental | Other: Cardiovascular rehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any individual aged 18 years and older who has been diagnosed with peripheral artery disease, coronary artery disease, angina, ischemic heart failure, transient ischemic attack or ischemic stroke (non-cardioembolic, non-hemorrhagic);
- Have been admitted to the PREV program;
Key exclusion criteria (1 listed)
- Being not able to give written informed consent;
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 |
|---|---|---|
| Cardiovascular rehabilitation programThe cardiovascular rehabilitation program consists of a 12 weeks supervised exercises therapy (either in person or in tele-care) | Other | Cardiovascular rehabilitation program |
Primary outcome
Change in toe pressure measurement
Time frame: Change from baseline to 12 weeks
Results will be measured in mm Hg
Change in the toe-brachial index
Time frame: Change from baseline to 12 weeks
Change in the ankle-brachial index
Time frame: Change from baseline to 12 weeks
2 secondary outcomes
Change in 6-minute walk test (6MWT)
Time frame: Change from Baseline to 12 weeks
Short Form Health Survey 36 (SF-36)
Time frame: Change from baseline to 12 weeks
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 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular rehabilitation program in people with Peripheral Artery Disease (PAD) and Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by Laval University at 1 site in Canada.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. 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 Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in toe pressure measurement (time frame: Change from baseline to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.