Acute Coronary SyndromeREMOTE-ACSNCT05385341
Rehabilitation Exercise With MObile Technology and Education After Acute Coronary Syndrome
A study testing Telerehabilitation (Tele RCV) and Rehabilitation (RCV) in people with Acute Coronary Syndrome, run by University Hospital, Toulouse.
Trial summary
Despite a clear indication of grade Ia, cardiac rehabilitation (CR) is dramatically underutilized after acute coronary syndrome with less than 30% of patients addressed in France. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Telerehabilitation (Tele RCV) and Rehabilitation (RCV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with acute coronary syndrome less than 6 months,
- Addressed to ambulatory cardiac rehabilitation,
- Equipped with a smartphone compatible with the protocol's application, connected to web
- Having signed an informed consent,
- Affiliated to the french national health insurance.
Who cannot join
- Incapacity to use application on smartphone,
- Contraindication to exercise training,
- Pregnancy,
- Juridic protection
- Left ventricular ejection fraction < 45%
- Significate ventricular arrhythmia (frequent or polymorph PVC during initial exercise testing, ventricular tachycardia or sudden cardiac death at the beginning)
Show all 12Show fewer
- Flutter or atrial fibrillation (transient or permanent)
- Coronary revascularization needing supplementary procedure
- Residual myocardial ischemia determined by initial exercise testing or alternative testing (nuclear imaging or stress echocardiography)
- Mini Mental State < 26
- Patients living alone at home
- Comorbidities limiting participation to the protocol: kidney dialysis, insulin-requiring diabetes, residuals sequels of central and/or peripheral nervous system injuries
About this study
Official title: Is Tele-rehabilitation an Efficacious Alternative to Traditional Center Based Cardiac Rehabilitation After Acute Coronary Syndrome?
Despite a clear indication of grade Ia, cardiac rehabilitation (CR) is dramatically underutilized after acute coronary syndrome with less than 30% of patients addressed in France. Mobile technology has the potential to overcome barriers to access to cardiac rehabilitation and may be a useful tool for increasing participation. However, studies have to prove this type of care is as effective as traditional center based cardiac rehabilitation.
Read the detailed description
After acute coronary syndrome (ACS), it is recommended to propose a cardiac rehabilitation (CR) program in order to reduce the risk of recidive, to improve the quality of life and to reduce the risk of disabilities. Traditional CR which is most of the time center-based, is underutilized with less than 30% of patients addressed en France. Therefore, Télé-Cardiac Rehabilitation (Télé-RCV) has been developped progressively since the eighties showing comparable efficacity compared with CR concerning physical fitness. The investigative team, had previously published results showing that telephone support guided by accelerometers could improve physical activity. However, In France, device allowing telemonitoring online of heart rate are not available. Moreover, the investigators have not yet developped remote therapeutic education which is proposed in CR programs. Thus, the present study planned to develop and evaluate aTele-RCV solution aimed to monitor exercise training at home and to educate remotely patient after ACS.
The device is an association of a heart rate monitor, a blood pressure testing, a balance linked with a full web secured application connecting patient and caregivers. In the intervention group, Tele-RCV is proposed during 20 sessions containing 2h of exercise training combined with 6h of therapeutic tele-education. In the control group, CR is proposed during 20 sessions with the same volume of exercise training and therapeutic education. After randomisation, patient are allocated to one of the two groups. The evaluation of the primary and secondary outcomes are realized at the beginning, at one month (only walking tests) and at 2 months. A social evaluation is done in parallel to test the acceptability for the Télé-RCV compared with CR.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Telerehabilitation (Tele RCV), Rehabilitation (RCV)
- Keywords
- Cardiac rehabilitation, Tele-health
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation (Tele RCV)Other
20 home-based sessions monitored by the REMOTE-ACS device and containing 2 hours/day 5 days/7 of exercise training associated with educative sessions.
Rehabilitation (RCV)Other
20 sessions of cardiac rehabilitation will be realized in a rehabilitation center containing exercise training during 2 hours/day 5 days/7 and educative program.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation (Tele RCV) | Experimental | Experimental group (Tele-RCV): the treatment will consist of 20 home-based sessions monitored by the REMOTE-ACS device and containing 2 hours/day 5 days/7 of exercise training (the first session in center to form the patient) associated with 8 educative sessions. Receives: Other: Telerehabilitation (Tele RCV) |
| Rehabilitation (RCV) | Active comparator | Group control (RCV) : 20 sessions of cardiac rehabilitation will be realized in a rehabilitation center containing exercise training during 2 hours/day 5 days/7 and educative program. Receives: Other: Rehabilitation (RCV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect analysis 2 month after inclusion
Change of the peak oxygen volume at 2 months after inclusion
Measured: 2 months
Secondary outcomes (9)
Effect analysis 1 month after inclusion
Analysis of change between T0 and 1 month concerning the walking tests : distance traveled in meters
Measured: 1 month
Effect analysis 1 month after inclusion
Analysis of change between T0 and 1 month concerning the number of Tele-RCV or RCV sessions realized
Measured: 1 month
Effect analysis 2 months after inclusion
Analysis of change between T0 and 2 months concerning the walking tests:distance traveled in meters
Measured: 2 months
Effect analysis 2 months after inclusion
Analysis of change between T0 and 2 months concerning the number of Tele-RCV or RCV sessions realized
Measured: 2 months
Health economics criteria
Incremental Cost-effectiveness ratios of the REMOTE-ACS device compared with the traditional cardiac rehabilitation after acute coronary syndrome according to the French national health insurance perspective and 2 months follow-up period.
Measured: 26 months
Health economics criteria
Cost-utility ratios of the REMOTE-ACS device compared with the traditional cardiac rehabilitation after acute coronary syndrome according to the French national health insurance perspective and 2 months follow-up period.
Measured: 26 months
Production cost of the REMOTE-ACS device
Production cost of the REMOTE-ACS device by micro costing, according the hospital perspective
Measured: 26 months
Acceptability of the device
The acceptability will be assessed by a sociological point of view based on collective meeting (with patient and caregivers) and individual questionnaires for the two groups before randomization and after the program only for the Tele-RCV group.
Measured: 26 months
Satisfaction of the device
The satisfaction will be assessed by a questionnaire of satisfaction titled: Cardiovascular rehabilitation program satisfaction questionnaire, with 8 questions, the minimum value is "nothing", and the maximum value is "very important"
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study startDec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: The start of the study took too long and there are already many publications on the subject
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meyer ELBAZ, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385341
- Sponsor's protocol ID
- RC31/18/0474
- Acronym
- REMOTE-ACS
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2020
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Tele-rehabilitation an Efficacious Alternative to Traditional Center Based Cardiac Rehabilitation After Acute Coronary Syndrome?
- ClinicalTrials.gov ID
- NCT05385341
- Acronym / sponsor ID
- REMOTE-ACS / RC31/18/0474
- Conditions
- Acute Coronary Syndrome
- Keywords
- Cardiac rehabilitation, Tele-health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The start of the study took too long and there are already many publications on the subject
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 May 2022 (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.
Despite a clear indication of grade Ia, cardiac rehabilitation (CR) is dramatically underutilized after acute coronary syndrome with less than 30% of patients addressed in France. Mobile technology has the potential to overcome barriers to access to cardiac rehabilitation and may be a useful tool for increasing participation. However, studies have to prove this type of care is as effective as traditional center based cardiac rehabilitation.
Detailed description
After acute coronary syndrome (ACS), it is recommended to propose a cardiac rehabilitation (CR) program in order to reduce the risk of recidive, to improve the quality of life and to reduce the risk of disabilities. Traditional CR which is most of the time center-based, is underutilized with less than 30% of patients addressed en France. Therefore, Télé-Cardiac Rehabilitation (Télé-RCV) has been developped progressively since the eighties showing comparable efficacity compared with CR concerning physical fitness. The investigative team, had previously published results showing that telephone support guided by accelerometers could improve physical activity. However, In France, device allowing telemonitoring online of heart rate are not available. Moreover, the investigators have not yet developped remote therapeutic education which is proposed in CR programs. Thus, the present study planned to develop and evaluate aTele-RCV solution aimed to monitor exercise training at home and to educate remotely patient after ACS.
The device is an association of a heart rate monitor, a blood pressure testing, a balance linked with a full web secured application connecting patient and caregivers. In the intervention group, Tele-RCV is proposed during 20 sessions containing 2h of exercise training combined with 6h of therapeutic tele-education. In the control group, CR is proposed during 20 sessions with the same volume of exercise training and therapeutic education. After randomisation, patient are allocated to one of the two groups. The evaluation of the primary and secondary outcomes are realized at the beginning, at one month (only walking tests) and at 2 months. A social evaluation is done in parallel to test the acceptability for the Télé-RCV compared with CR.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation (Tele RCV) | Experimental | Other: Telerehabilitation (Tele RCV)Experimental group (Tele-RCV): the treatment will consist of 20 home-based sessions monitored by the REMOTE-ACS device and containing 2 hours/day 5 days/7 of exercise training (the first session in center to form the patient) associated with 8 educative sessions. |
| Rehabilitation (RCV) | Active comparator | Other: Rehabilitation (RCV)Group control (RCV) : 20 sessions of cardiac rehabilitation will be realized in a rehabilitation center containing exercise training during 2 hours/day 5 days/7 and educative program. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with acute coronary syndrome less than 6 months,
- Addressed to ambulatory cardiac rehabilitation,
- Equipped with a smartphone compatible with the protocol's application, connected to web
- Having signed an informed consent,
- Affiliated to the french national health insurance.
Key exclusion criteria (12 listed)
- Incapacity to use application on smartphone,
- Contraindication to exercise training,
- Pregnancy,
- Juridic protection
- Left ventricular ejection fraction < 45%
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 |
|---|---|---|
| Telerehabilitation (Tele RCV)20 home-based sessions monitored by the REMOTE-ACS device and containing 2 hours/day 5 days/7 of exercise training associated with educative sessions. | Other | Telerehabilitation (Tele RCV) |
| Rehabilitation (RCV)20 sessions of cardiac rehabilitation will be realized in a rehabilitation center containing exercise training during 2 hours/day 5 days/7 and educative program. | Other | Rehabilitation (RCV) |
Primary outcome
Effect analysis 2 month after inclusion
Time frame: 2 months
Change of the peak oxygen volume at 2 months after inclusion
9 secondary outcomes
Effect analysis 1 month after inclusion
Time frame: 1 month
Effect analysis 1 month after inclusion
Time frame: 1 month
Effect analysis 2 months after inclusion
Time frame: 2 months
Effect analysis 2 months after inclusion
Time frame: 2 months
Health economics criteria
Time frame: 26 months
Health economics criteria
Time frame: 26 months
Production cost of the REMOTE-ACS device
Time frame: 26 months
Acceptability of the device
Time frame: 26 months
Satisfaction of the device
Time frame: 26 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- 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. This study is not recruiting at the moment.
Meyer ELBAZ, MD principal investigator
University Hospital, Toulouse
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation (Tele RCV) and Rehabilitation (RCV) in people with Acute Coronary Syndrome, run by University Hospital, Toulouse.
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 5 inclusion and 12 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: withdrawn, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Effect analysis 2 month after inclusion (time frame: 2 months). 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 30 Jun 2026.