Acute Coronary SyndromeNCT04294940
Impact of a Digital Solution (CardiCare™) on Cardiorespiratory Fitness Improvement in Patients Discharged From a Phase 2 Cardiac Rehabilitation Following an Acute Coronary Syndrome
A study testing Wear an actigraph and Use the mobile application CardiCare™ and wear an actigraph in people with Acute Coronary Syndrome, run by Ad scientiam at 10 sites in 4 countries.
Trial summary
Coronary heart disease is a partial inability of the coronary arteries to supply the heart muscle due to their narrowing. There is angina and myocardial infarction. Coronary heart disease is the first cause of non-communicated deaths and years of life lost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Wear an actigraph and Use the mobile application CardiCare™ and wear an actigraph
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Dec 2021to Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥ 18 years old.
- Diagnosis of an Acute Coronary Syndrome in the last 3 months, documented by angiographically-proven coronary artery disease or hospitalisation report.
- Graduated from a phase 2 cardiac rehabilitation, ready to enter a phase 3 CR at home.
- Having agreed to perform a cardiopulmonary exercise testing and blood count at the inclusion or having performed a cardiopulmonary exercise testing and blood count within the last week.
- Owning a personal smartphone (Android 5.0 or beyond / iPhone 5s and newer supporting IOS 12 and beyond) with Wifi or a data plan (3G/4G).
- Able to use a smartphone (e.g. no vision, hearing, cognitive or dexterity impairment).
Show all 28Show fewer
- Having agreed to install CardiCare™ application on their own smartphone.
- Having agreed to wear an actigraph at all times and install the actigraph application (CenterPoint Sync) on their smartphone.
- Enrolled in or benefiting of a national health system.
- Having read the information sheet and signed the informed consent form.
- Non-inclusion Criteria:
- Treated with Coronary Artery Bypass Grafting.
- Cardiac surgery in the last 12 weeks.
- Planned revascularisation or surgery in the next 6 months.
- Clinical heart failure or Left Ventricular Ejection Fraction < 40% documented within the last 2 months.
- Severe valvular disease.
- Severe pulmonary disease.
- Chronic kidney disease (stages III-V).
- Drug or/and alcohol abuse (as per clinician's judgment).
- Unstable angina.
- Osteoarticular condition or other reasons that limit exercise for more than 4 months (clinician's judgment).
- Uncontrolled hypertension (resting Diastolic BP>100 mmHg and resting Systolic BP >200 mmHg).
- Severe/uncontrolled arrhythmia.
- Systemic medical diseases that are likely to affect cognitive functioning.
- Pregnant women confirmed by a pregnancy test at the inclusion.
- Participation to another interventional clinical trial (category 1).
- Illiterate or not proficient in the language of the study country (French, Italian, Spanish or Portuguese according to the country).
- Person under guardianship or curatorship.
Who cannot join
None listed.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
France4 sites
Corentin Celton hospital
Issy-les-Moulineaux
Lariboisière hospital
Paris
Saint-Yves clinic
Rennes
Brie Cardiac Readaptation Centre
Villeneuve-Saint-Denis
Italy2 sites
Maugeri Scientific Clinical Institutes
Pavia
Scientific Institute of Hospitalization and Care San Raffaele Pisana
Roma
Portugal2 sites
CHOL - Santa Cruz hospital
Carnaxide
CHULN - Santa Marta hospital
Lisbon
Spain2 sites
Carlos III - La Paz Hospital
Madrid
Santiago University Hospital
Santiago de Compostela
About this study
Coronary heart disease is a partial inability of the coronary arteries to supply the heart muscle due to their narrowing. There is angina and myocardial infarction. Coronary heart disease is the first cause of non-communicated deaths and years of life lost.
After hospital discharge, a few days following the acute care of a coronary heart disease, a formal Cardiac Rehabilitation programme (CR) is usually provided. CR is a comprehensive programme involving exercise training, risk factor modification, education and psychological support. It is generally sequenced in 4 phases. Phase 1 begins at the hospital and consists of early mobilisation and education. Most phase 2 CR models are based upon supervised ambulatory outpatient programmes. Maintenance (phase 3 and 4) follows the ambulatory programme in which physical fitness and risk factor control are supported in a minimally supervised setting.
Read more
Despite high-grade recommendations and abundant clinical evidence, a CR program is not always implemented and the patients are not systematically referred after discharge from a phase 1 CR. Furthermore, compliance to pharmacological treatments and changes in lifestyle and diet are hugely neglected following a phase 2 CR and an important number of patients resume a sedentary lifestyle.
A growing body of evidence supports the use of digital tools such as smartphones and tablets in helping the patients achieve their goals in terms of physical exercise, risk-factor reduction and diet improvement.
Ad Scientiam has developed CardiCare™, a mobile application intended to provide a personalised physical training plan contributing to stabilise or improve cardiorespiratory fitness through improvement of VO2max.
The mobile application CardiCare™ is to be used by patients after an acute coronary syndrome, graduated from a phase 2 cardiac rehabilitation program in a cardiac rehabilitation centre and entering in phase 3 CR.
The mobile application CardiCare™ consists of several modules:
- A physical activity recommendation engine, providing personalised weekly activity schedule, self-adapting to the patient's clinical characteristics, physical capacity and sport preferences through a proprietary algorithm
- Self-administered questionnaires to assess perceived exertion, chest pain, weight variations, patient's quality of life
- Passive monitoring of the patient's physical activity through Apple's HealthKit and Google's Fit
- Informational content about cardiovascular diseases, risk factor reduction and chest pain action plan The investigator's work hypothesis is that, compared to standard care, CardiCare™ will stabilise or improve the cardiorespiratory fitness (VO2max) acquired post-CR.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Wear an actigraph, Use the mobile application CardiCare™ and wear an actigraph
- Keywords
- CardiCare, Coronary heart disease, Application, Mobile, Acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wear an actigraphOther
Between visits, tha patient will have to:
- Follow the hygiene-dietetic recommendations given by their centre.
- Wear the actigraph night and day Patients
Use the mobile application CardiCare™ and wear an actigraphOther
Between visits, tha patient will have to:
- Follow the hygiene-dietetic recommendations given by their centre.
- Wear the actigraph night and day Patients
- wear their smartphone everyday and use the mobile application CardiCare™
| Study group | Role | What they receive |
|---|---|---|
| Group A: standard of care | Other | The patient will follow the hygiene-dietetic recommendations given by their centre and wear an actigraph night and day. Receives: Other: Wear an actigraph |
| Group B: standard of care + mobile application CardiCare™ | Other | The patient will follow the hygiene-dietetic recommendations given by their centre, wear an actigraph night and day and use the mobile application CardiCare™ Receives: Other: Use the mobile application CardiCare™ and wear an actigraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy at 6 months of CardiCare™ in stabilising or improving the Cardiorespiratory Fitness of patients after acute coronary syndrome, graduated from a phase 2 cardiac rehabilitation program, versus standard care.
Proportion of participants with stabilised or improved VO2max 6 months, as measured by Cardiopulmonary Exercise Test in group B versus group A
Measured: From day 0 to month 6
Secondary outcomes (22)
To evaluate CardiCare™ impact on global physical activity between both groups over time of follow-up.
The global physical activity will be monitored using continuous variables of the actigraph
Measured: From day 0 to month 6
To evaluate CardiCare™ impact on change in cardiorespiratory fitness at 3 months versus baseline in both groups.
Proportion of participants in group B versus group A with stabilised or improved VO2max at 3 months compared to baseline.
Measured: From day 0 to month 3
To evaluate CardiCare™ impact on change in other cardiorespiratory fitness parameters at 3 and 6 months versus baseline, in both groups
Comparison in continous measurement of cardiorespiratory fitness as measured by Cardiopulmonary Exercise Test
Measured: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on change in lipid levels at 3 and 6 months versus baseline, in both groups.
Identification of items will be based in continuous measurement of total cholesterol, Low Density Lipoproteins Cholesterol, High Density lipoproteins Cholesterol.
Measured: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on change in glucose levels at 3 and 6 months versus baseline, in both groups.
Identification of items will be based in continuous measurement of fasting glucose
Measured: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on change in weight at 3 months and 6 months versus baseline in both groups.
Identification of items will be based on measured clinical exam
Measured: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on change in Body Mass Index at 3 months and 6 months versus baseline in both groups.
Identification of items will be based on measured clinical exam
Measured: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on change in Hip and waist circumference at 3 months and 6 months versus baseline in both groups.
Identification of items will be based on measured clinical exam
Measured: From day 0 to month 3 and month 6
To evaluate the impact of CardiCare™ on anxiety at 3 and 6 months versus baseline, in both groups.
Identification of the items will be measure with Hospital Anxiety and Depression Scale questionnaires
Measured: From day 0 to month 3 and month 6
To evaluate the impact of CardiCare™ on quality of life at 3 and 6 months versus baseline, in both groups.
Identification of the items will be measure with Health-Related Quality of Life questionnaires
Measured: From day 0 to month 3 and month 6
To evaluate medication compliance in both groups.
Compliance will based on the duration of medication interruption.
Measured: From day 0 to month 6
To compare differences of reported cardiovascular events at 3 and 6 months, in both groups.
Comparison will based on the number of cardiovascular events occured
Measured: From day 0 to month 3 and month 6
To compare time to first hospital readmission among both groups (all-cause, cardiac, and noncardiac) and their predictors.
Comparison will based on the number of hospital readmission
Measured: From day 0 to month 3 and month 6
To assess the cost-effectiveness to reduce 30-day, 3 months and 6 months readmission rates using CardiCare™ as an intervention compared to standard care.
Identification of the items based on the number of hospital readmission
Measured: From day 0 to month 3 and month 6
To evaluate the impact of CardiCare™ on employment status at 3 and 6 months versus baseline in both groups.
Identification of the items will based on the time to return to work and the time in sick leave
Measured: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on exercise performed in group B.
Comparison of the exercise performed during the follow up of participants in group B.
Measured: From day 0 to month 6
To evaluate CardiCare™ impact on cardiovascular risk factors control at 3 and 6 months versus baseline in both groups.
Identification of the cardiovascular risk factors will based on the clinical exam and blood tests
Measured: From day 0 to month 3 and month 6
To evaluate, for each session, the correlation between self-reported physical activities in CardiCare™ and those collected by the actigraph in group B.
Identification of items will be based on the physical activities reported by the patient in CardiCare™ and actigraph
Measured: From day 0 to month 6
To identify patterns of VO2max evolution between D0, M3 and M6, between both groups
Identification of items will be based on the measures of cardiorespiratory fitness as measured by Cardiopulmonary Exercise Test
Measured: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on sleep quality between groups over time of follow-up.
Identification of the items be based on actigraph
Measured: From day 0 to month 6
To evaluate the safety of the CardiCare™ use.
Safety will be assessed by the numbers of adverse events and adverse events related to the use of the application CardiCare™.
Measured: From day 0 to month 6
To collect patients and investigators feedback on the CardiCare™ application.
Descriptive analysis of patients and investigators satisfaction related to the mobile application.
Measured: From day 0 to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study startDec 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Study suspended due to the COVID-19 pandemic. Some study procedures are not curently possible for many investigational sites.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ad scientiam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Cohen Solal, Prof, Principal investigator, Hopital Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294940
- Sponsor's protocol ID
- CardiCare
- Status last verified
- Jun 2021
- First submitted
- 25 Feb 2020
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
PubMed 34741536
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Digital Solution (CardiCare™) on Cardiorespiratory Fitness Improvement in Patients Discharged From a Phase 2 Cardiac Rehabilitation Following an Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04294940
- Acronym / sponsor ID
- CardiCare
- Conditions
- Acute Coronary Syndrome
- Keywords
- CardiCare, Coronary heart disease, Application, Mobile, Acute coronary syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study suspended due to the COVID-19 pandemic. Some study procedures are not curently possible for many investigational sites.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ad scientiamUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Mar 2020 (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.
Coronary heart disease is a partial inability of the coronary arteries to supply the heart muscle due to their narrowing. There is angina and myocardial infarction. Coronary heart disease is the first cause of non-communicated deaths and years of life lost.
After hospital discharge, a few days following the acute care of a coronary heart disease, a formal Cardiac Rehabilitation programme (CR) is usually provided. CR is a comprehensive programme involving exercise training, risk factor modification, education and psychological support. It is generally sequenced in 4 phases. Phase 1 begins at the hospital and consists of early mobilisation and education. Most phase 2 CR models are based upon supervised ambulatory outpatient programmes. Maintenance (phase 3 and 4) follows the ambulatory programme in which physical fitness and risk factor control are supported in a minimally supervised setting.
Despite high-grade recommendations and abundant clinical evidence, a CR program is not always implemented and the patients are not systematically referred after discharge from a phase 1 CR. Furthermore, compliance to pharmacological treatments and changes in lifestyle and diet are hugely neglected following a phase 2 CR and an important number of patients resume a sedentary lifestyle.
A growing body of evidence supports the use of digital tools such as smartphones and tablets in helping the patients achieve their goals in terms of physical exercise, risk-factor reduction and diet improvement.
Ad Scientiam has developed CardiCare™, a mobile application intended to provide a personalised physical training plan contributing to stabilise or improve cardiorespiratory fitness through improvement of VO2max.
The mobile application CardiCare™ is to be used by patients after an acute coronary syndrome, graduated from a phase 2 cardiac rehabilitation program in a cardiac rehabilitation centre and entering in phase 3 CR.
The mobile application CardiCare™ consists of several modules:
- A physical activity recommendation engine, providing personalised weekly activity schedule, self-adapting to the patient's clinical characteristics, physical capacity and sport preferences through a proprietary algorithm
- Self-administered questionnaires to assess perceived exertion, chest pain, weight variations, patient's quality of life
- Passive monitoring of the patient's physical activity through Apple's HealthKit and Google's Fit
- Informational content about cardiovascular diseases, risk factor reduction and chest pain action plan The investigator's work hypothesis is that, compared to standard care, CardiCare™ will stabilise or improve the cardiorespiratory fitness (VO2max) acquired post-CR.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: standard of care | Other | Other: Wear an actigraphThe patient will follow the hygiene-dietetic recommendations given by their centre and wear an actigraph night and day. |
| Group B: standard of care + mobile application CardiCare™ | Other | Other: Use the mobile application CardiCare™ and wear an actigraphThe patient will follow the hygiene-dietetic recommendations given by their centre, wear an actigraph night and day and use the mobile application CardiCare™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Subjects ≥ 18 years old.
- Diagnosis of an Acute Coronary Syndrome in the last 3 months, documented by angiographically-proven coronary artery disease or hospitalisation report.
- Graduated from a phase 2 cardiac rehabilitation, ready to enter a phase 3 CR at home.
- Having agreed to perform a cardiopulmonary exercise testing and blood count at the inclusion or having performed a cardiopulmonary exercise testing and blood count within the last week.
- Owning a personal smartphone (Android 5.0 or beyond / iPhone 5s and newer supporting IOS 12 and beyond) with Wifi or a data plan (3G/4G).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Wear an actigraphBetween visits, tha patient will have to: * Follow the hygiene-dietetic recommendations given by their centre. * Wear the actigraph night and day Patients | Other | Group A: standard of care |
| Use the mobile application CardiCare™ and wear an actigraphBetween visits, tha patient will have to: * Follow the hygiene-dietetic recommendations given by their centre. * Wear the actigraph night and day Patients * wear their smartphone everyday and use the mobile application CardiCare™ | Other | Group B: standard of care + mobile application CardiCare™ |
Primary outcome
To evaluate the efficacy at 6 months of CardiCare™ in stabilising or improving the Cardiorespiratory Fitness of patients after acute coronary syndrome, graduated from a phase 2 cardiac rehabilitation program, versus standard care.
Time frame: From day 0 to month 6
Proportion of participants with stabilised or improved VO2max 6 months, as measured by Cardiopulmonary Exercise Test in group B versus group A
22 secondary outcomes
To evaluate CardiCare™ impact on global physical activity between both groups over time of follow-up.
Time frame: From day 0 to month 6
To evaluate CardiCare™ impact on change in cardiorespiratory fitness at 3 months versus baseline in both groups.
Time frame: From day 0 to month 3
To evaluate CardiCare™ impact on change in other cardiorespiratory fitness parameters at 3 and 6 months versus baseline, in both groups
Time frame: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on change in lipid levels at 3 and 6 months versus baseline, in both groups.
Time frame: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on change in glucose levels at 3 and 6 months versus baseline, in both groups.
Time frame: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on change in weight at 3 months and 6 months versus baseline in both groups.
Time frame: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on change in Body Mass Index at 3 months and 6 months versus baseline in both groups.
Time frame: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on change in Hip and waist circumference at 3 months and 6 months versus baseline in both groups.
Time frame: From day 0 to month 3 and month 6
To evaluate the impact of CardiCare™ on anxiety at 3 and 6 months versus baseline, in both groups.
Time frame: From day 0 to month 3 and month 6
To evaluate the impact of CardiCare™ on quality of life at 3 and 6 months versus baseline, in both groups.
Time frame: From day 0 to month 3 and month 6
To evaluate medication compliance in both groups.
Time frame: From day 0 to month 6
To compare differences of reported cardiovascular events at 3 and 6 months, in both groups.
Time frame: From day 0 to month 3 and month 6
To compare time to first hospital readmission among both groups (all-cause, cardiac, and noncardiac) and their predictors.
Time frame: From day 0 to month 3 and month 6
To assess the cost-effectiveness to reduce 30-day, 3 months and 6 months readmission rates using CardiCare™ as an intervention compared to standard care.
Time frame: From day 0 to month 3 and month 6
To evaluate the impact of CardiCare™ on employment status at 3 and 6 months versus baseline in both groups.
Time frame: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on exercise performed in group B.
Time frame: From day 0 to month 6
To evaluate CardiCare™ impact on cardiovascular risk factors control at 3 and 6 months versus baseline in both groups.
Time frame: From day 0 to month 3 and month 6
To evaluate, for each session, the correlation between self-reported physical activities in CardiCare™ and those collected by the actigraph in group B.
Time frame: From day 0 to month 6
To identify patterns of VO2max evolution between D0, M3 and M6, between both groups
Time frame: From day 0 to month 3 and month 6
To evaluate CardiCare™ impact on sleep quality between groups over time of follow-up.
Time frame: From day 0 to month 6
To evaluate the safety of the CardiCare™ use.
Time frame: From day 0 to month 6
To collect patients and investigators feedback on the CardiCare™ application.
Time frame: From day 0 to month 6
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 29 Jun 2021.
- Derived from this study: PubMed 34741536Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
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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.
Alain Cohen Solal, Prof principal investigator
Hopital Lariboisière
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wear an actigraph and Use the mobile application CardiCare™ and wear an actigraph in people with Acute Coronary Syndrome, run by Ad scientiam at 10 sites in 4 countries.
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 28 inclusion and 0 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 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Italy, Portugal, Spain. 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?
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?
To evaluate the efficacy at 6 months of CardiCare™ in stabilising or improving the Cardiorespiratory Fitness of patients after acute coronary syndrome, graduated from a phase 2 cardiac rehabilitation program, versus standard care. (time frame: From day 0 to month 6). 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 NCT04294940, which also lists 1 linked publication.
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 29 Jun 2021.