Status:
WITHDRAWN
Impact of a Digital Solution (CardiCare™) on Cardiorespiratory Fitness Improvement in Patients Discharged From a Phase 2 Cardiac Rehabilitation Following an Acute Coronary Syndrome
Lead Sponsor:
Ad scientiam
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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).
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04294940
Start Date
December 1 2021
End Date
December 1 2023
Last Update
June 29 2021
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Corentin Celton hospital
Issy-les-Moulineaux, France
2
Lariboisière hospital
Paris, France
3
Saint-Yves clinic
Rennes, France
4
Brie Cardiac Readaptation Centre
Villeneuve-Saint-Denis, France