[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100385148":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":23,"locations":33,"responsibleParty":123,"collaborators":23,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":23,"eligibilityCriteria":130,"healthyVolunteers":127,"sex":131,"minAge":132,"maxAge":23,"enrollmentInfo":133,"targetDuration":23,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":148,"whyStopped":149,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Ad scientiam","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Group A: standard of care","The patient will follow the hygiene-dietetic recommendations given by their centre and wear an actigraph night and day.",[12],"Other: Wear an actigraph",{"label":14,"type":6,"description":15,"interventionNames":16},"Group B: standard of care + mobile application CardiCare™","The patient will follow the hygiene-dietetic recommendations given by their centre, wear an actigraph night and day and use the mobile application CardiCare™",[17],"Other: Use the mobile application CardiCare™ and wear an actigraph",[19,24],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Wear an actigraph","Between visits, tha patient will have to:\n\n* Follow the hygiene-dietetic recommendations given by their centre.\n* Wear the actigraph night and day Patients",[9],null,{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Use the mobile application CardiCare™ and wear an actigraph","Between visits, tha patient will have to:\n\n* Follow the hygiene-dietetic recommendations given by their centre.\n* Wear the actigraph night and day Patients\n* wear their smartphone everyday and use the mobile application CardiCare™",[14],[29],{"name":30,"affiliation":31,"role":32},"Alain Cohen Solal, Prof","Hopital Lariboisière","PRINCIPAL_INVESTIGATOR",[34,45,53,61,69,79,87,97,105,115],{"facility":35,"status":23,"city":36,"state":23,"zip":23,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":23},"Corentin Celton hospital","Issy-les-Moulineaux","France","FR",{"type":40,"coordinates":41},"Point",[42,43],2.27718,48.82104,{"lat":43,"lon":42},{"facility":46,"status":23,"city":47,"state":23,"zip":23,"country":37,"countryCode":38,"cosmosGeoPoint":48,"geoPoint":52,"contacts":23},"Lariboisière hospital","Paris",{"type":40,"coordinates":49},[50,51],2.3488,48.85341,{"lat":51,"lon":50},{"facility":54,"status":23,"city":55,"state":23,"zip":23,"country":37,"countryCode":38,"cosmosGeoPoint":56,"geoPoint":60,"contacts":23},"Saint-Yves clinic","Rennes",{"type":40,"coordinates":57},[58,59],-1.67431,48.11109,{"lat":59,"lon":58},{"facility":62,"status":23,"city":63,"state":23,"zip":23,"country":37,"countryCode":38,"cosmosGeoPoint":64,"geoPoint":68,"contacts":23},"Brie Cardiac Readaptation Centre","Villeneuve-Saint-Denis",{"type":40,"coordinates":65},[66,67],2.79353,48.81578,{"lat":67,"lon":66},{"facility":70,"status":23,"city":71,"state":23,"zip":23,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":23},"Maugeri Scientific Clinical Institutes","Pavia","Italy","IT",{"type":40,"coordinates":75},[76,77],9.15917,45.19205,{"lat":77,"lon":76},{"facility":80,"status":23,"city":81,"state":23,"zip":23,"country":72,"countryCode":73,"cosmosGeoPoint":82,"geoPoint":86,"contacts":23},"Scientific Institute of Hospitalization and Care San Raffaele Pisana","Roma",{"type":40,"coordinates":83},[84,85],11.10642,44.99364,{"lat":85,"lon":84},{"facility":88,"status":23,"city":89,"state":23,"zip":23,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":96,"contacts":23},"CHOL - Santa Cruz hospital","Carnaxide","Portugal","PT",{"type":40,"coordinates":93},[94,95],-9.24671,38.72706,{"lat":95,"lon":94},{"facility":98,"status":23,"city":99,"state":23,"zip":23,"country":90,"countryCode":91,"cosmosGeoPoint":100,"geoPoint":104,"contacts":23},"CHULN - Santa Marta hospital","Lisbon",{"type":40,"coordinates":101},[102,103],-9.1498,38.72509,{"lat":103,"lon":102},{"facility":106,"status":23,"city":107,"state":23,"zip":23,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":114,"contacts":23},"Carlos III - La Paz Hospital","Madrid","Spain","ES",{"type":40,"coordinates":111},[112,113],-3.70256,40.4165,{"lat":113,"lon":112},{"facility":116,"status":23,"city":117,"state":23,"zip":23,"country":108,"countryCode":109,"cosmosGeoPoint":118,"geoPoint":122,"contacts":23},"Santiago University Hospital","Santiago de Compostela",{"type":40,"coordinates":119},[120,121],-8.54569,42.88052,{"lat":121,"lon":120},{"type":124,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100385148","impact-of-a-digital-solution-cardicare-on-cardiorespiratory-fitness-improvement-in-patients-discharged-from-a-phase-2-cardiac-rehabilitation-following-an-acute-coronary-syndrome-100385148",false,"NCT04294940","Impact of a Digital Solution (CardiCare™) on Cardiorespiratory Fitness Improvement in Patients Discharged From a Phase 2 Cardiac Rehabilitation Following an Acute Coronary Syndrome","Inclusion Criteria:\n\n* Subjects ≥ 18 years old.\n* Diagnosis of an Acute Coronary Syndrome in the last 3 months, documented by angiographically-proven coronary artery disease or hospitalisation report.\n* Graduated from a phase 2 cardiac rehabilitation, ready to enter a phase 3 CR at home.\n* 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.\n* Owning a personal smartphone (Android 5.0 or beyond \u002F iPhone 5s and newer supporting IOS 12 and beyond) with Wifi or a data plan (3G\u002F4G).\n* Able to use a smartphone (e.g. no vision, hearing, cognitive or dexterity impairment).\n* Having agreed to install CardiCare™ application on their own smartphone.\n* Having agreed to wear an actigraph at all times and install the actigraph application (CenterPoint Sync) on their smartphone.\n* Enrolled in or benefiting of a national health system.\n* Having read the information sheet and signed the informed consent form.\n\nNon-inclusion Criteria:\n\n* Treated with Coronary Artery Bypass Grafting.\n* Cardiac surgery in the last 12 weeks.\n* Planned revascularisation or surgery in the next 6 months.\n* Clinical heart failure or Left Ventricular Ejection Fraction \\\u003C 40% documented within the last 2 months.\n* Severe valvular disease.\n* Severe pulmonary disease.\n* Chronic kidney disease (stages III-V).\n* Drug or\u002Fand alcohol abuse (as per clinician's judgment).\n* Unstable angina.\n* Osteoarticular condition or other reasons that limit exercise for more than 4 months (clinician's judgment).\n* Uncontrolled hypertension (resting Diastolic BP\\>100 mmHg and resting Systolic BP \\>200 mmHg).\n* Severe\u002Funcontrolled arrhythmia.\n* Systemic medical diseases that are likely to affect cognitive functioning.\n* Pregnant women confirmed by a pregnancy test at the inclusion.\n* Participation to another interventional clinical trial (category 1).\n* Illiterate or not proficient in the language of the study country (French, Italian, Spanish or Portuguese according to the country).\n* Person under guardianship or curatorship.","ALL","18 Years",{"count":134,"type":135},0,"ACTUAL","INTERVENTIONAL",[138],"NA","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.\n\nAfter 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.\n\nDespite 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.\n\nA 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.\n\nAd 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.\n\nThe 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.\n\nThe mobile application CardiCare™ consists of several modules:\n\n* 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\n* Self-administered questionnaires to assess perceived exertion, chest pain, weight variations, patient's quality of life\n* Passive monitoring of the patient's physical activity through Apple's HealthKit and Google's Fit\n* 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.",[141],"Acute Coronary Syndrome",[143,144,145,146,147],"CardiCare","Coronary heart disease","Application","Mobile","Acute coronary syndrome","WITHDRAWN","Study suspended due to the COVID-19 pandemic. Some study procedures are not curently possible for many investigational sites.","2021-06-24",{"date":152,"type":135},"2021-06-29",{"date":154,"type":155},"2021-12","ESTIMATED",{"date":157,"type":155},"2023-12",{"name":5,"class":6},10]