[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"angina-unstable\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:angina-unstable":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100606334","fapo-2-cardiac-patient-monitoring-tool-for-clinical-observation-and-arrhythmia-detection-100606334",false,"NCT07174206","FAPO-2: Cardiac Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection","FAPO-2","Inclusion Criteria:\n\n* Patients diagnosed with cardiovascular disease, of both sexes, aged over 22 years;\n* Provision of informed consent through signature of the Informed Consent Form (ICF);\n* Assentation to adhere to study procedures and requirements;\n* Patients indicated for outpatient follow-up due to a cardiovascular condition, or with clinical parameters indicating the need for conventional surgical or catheter-based interventions (e.g., catheter ablation for arrhythmias, transcatheter aortic valve implantation, percutaneous coronary intervention, etc.);\n* Low or no risk of skin injury, based on Braden Scale clinical criteria or clinical team assessment\n\nExclusion Criteria:\n\n* Presence of skin conditions, such as vitiligo, lupus, or atopic dermatitis, as well as tattoos on the wrist that may interfere with the smartwatch's optical sensor readings;\n* Known sensitivity or history of allergic reactions to components of the wearable devices or related items, such as adhesives or electrodes;\n* Inability to properly use the wearable monitoring devices due to physical, cognitive, or technological limitations;\n* Presence of a peripherally inserted central catheter (PICC) or arteriovenous fistula;\n* Presence of implanted cardiac devices, such as pacemakers, defibrillators, or cardiac resynchronization devices, which prevent ECG acquisition via smartwatch;\n* Diagnosis of conditions associated with narrowing or obstruction of the aorta and subclavian arteries (e.g., Stanford Type A chronic aortic dissection, Takayasu arteritis, Subclavian Steal Syndrome, or Kawasaki disease), which may cause discrepancies in blood pressure between upper limbs and interfere with study assessments.","ALL","22 Years",{"count":19,"type":20},520,"ESTIMATED","INTERVENTIONAL",[23],"NA","The FAPO-2 study (Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection) is a prospective, interventional, non-randomized study designed to evaluate the feasibility, usability, clinical effectiveness, and cost-efficiency of a wearable-enabled remote monitoring strategy in adult cardiac patients. The intervention consists of active clinical management of patients via teleconsultations, triggered by automated alerts generated through wearable data integrated into a centralized digital platform. FAPO-2 will include patients with chronic cardiovascular conditions and those undergoing recent minimally invasive interventions. The central objective is to validate a structured model for early arrhythmia detection, remote risk stratification, and timely clinical action. A total of 520 patients aged ≥22 years will be enrolled, stratified by sex (1:1), and followed at the Heart Institute (InCor) of the University of São Paulo. Participants will be allocated into one of four protocol groups:\n\nGroup 1 - Pilot (n=15): Healthy volunteers monitored for \\~14±3 days using both the smartwatch and a portable holter system to validate usability, skin tolerability, signal integrity, and data flow within the platform.\n\nGroup 2 - Extensive Outpatient Monitoring (n=150): Patients with chronic cardiovascular diseases monitored over a 45-day period. During 30 days, monitoring will be performed using a smartwatch to capture blood pressure, oxygen saturation, heart rate, and single-lead ECG. For 15 days, participants will use both the smartwatch (for HR and ECG) and a portable holter system.\n\nGroup 3 - Extensive Post-Intervention Monitoring (n=50): Patients recently undergoing procedures such as angioplasty, TAVI, or ablation, following the same monitoring protocol as Group 2.\n\nGroup 4 - Optimized Outpatient Monitoring (n=305): Patients with stable chronic cardiac disease monitored for 15±3 days, using both devices simultaneously for HR and ECG (smartwatch) and portable holter system.",[26,27,28],"Heart Diseases","Atrial Fibrillation (AF)","Angina, Unstable",[30,31,32,33,34,35],"Atrial Fibrillation","FAPO","PAOF","Telemonitoring","Digital Health","Arrhythmias","RECRUITING","2025-09-08",{"date":39,"type":40},"2025-09-15","ACTUAL",{"date":42,"type":40},"2025-02-07",{"date":44,"type":20},"2026-02-28",{"name":46,"class":47},"University of Sao Paulo","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":59,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":48},"100521900","complex-registry---a-prospective-cohort-study-to-describe-the-management-and-outcomes-of-patients-presenting-with-complex-and-calcified-coronary-artery-disease-100521900","NCT06075602","COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease","COMPLEX","Inclusion Criteria:\n\n* Subject \\>18 years of age\n* Individuals presenting with chronic, complex and\u002For calcified CAD and requiring PCI or CABG\n* Complex coronary artery disease \u002F lesions must include at least one of the following attributes:\n* Long and\u002F or heavily calcified coronary lesions\n* In-stent restenosis\n* Chronic total occlusions (CTO)\n* Left main lesions\n* Bifurcation lesions\n* Bypass graft lesions\n* Small vessel disease \u002F coronary microvascular dysfunction (e.g. not amenable to PCI)\n* Subjects must be willing to sign a patient informed consent (PIC) or must have signed the General Consent (GK).\n\nExclusion Criteria:\n\nThe presence of any one of the following exclusion criteria will lead to exclusion of the patient.\n\n* Patient is \\\u003C18 years of age\n* Patient unwilling or unable to provide informed consent\n* Patients with no complex and calcified CAD","18 Years",{"count":58,"type":20},5000,"10 Years","OBSERVATIONAL","The purpose of the COMPLEX Registry is to prospectively and retrospectively collect baseline, clinical and procedural data of patients who have undergone PCI or CABG for complex and\u002F or calcified chronic CAD, irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. The outcomes will be compared in different clinical subgroups (e.g. PCI vs. CABG). The impact of current PCI techniques\u002F devices, but also CABG strategies in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.",[63,64,65,66,67,68,69,70,28,71],"Coronary Disease","Coronary Artery Disease","Coronary Restenosis","Coronary Arteriosclerosis","Coronary Artery Calcification","Stable Chronic Angina","Angina Pectoris","Angina, Stable","Stent Thrombosis","2024-10-27",{"date":74,"type":40},"2024-10-29",{"date":76,"type":40},"2021-11-01",{"date":78,"type":20},"2031-12-31",{"name":80,"class":47},"Luzerner Kantonsspital",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":88,"targetDuration":59,"studyType":60,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":96,"locationsCount":48},"100438392","siroop-registry---a-prospective-registry-study-to-evaluate-the-outcomes-of-coronary-artery-disease-patients-treated-with-sirolimus-or-paclitaxel-eluting-balloon-catheters-100438392","NCT04988685","SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters","SIROOP","Inclusion Criteria:\n\n* Subject \\>18 years of age\n* Patients with significant acute or chronic coronary de-novo lesions or ISR lesions requiring treatment using PCI\n* Treatment with at least one DCB (device choice at the operator's discretion) In case of a patient with lesions treated at different procedural time, lesions will be separately collected and documented\n* Subjects must be willing to sign a patient informed consent (PIC) or must have signed the General Consent (GK).\n\nExclusion Criteria:\n\n* Patient is \\\u003C18 years of age\n* Patient unwilling or unable to provide informed consent\n* pregnancy and lactation\n* Indication for surgical revascularization",{"count":89,"type":20},2000,"The purpose of the SIROOP Registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone PCI and are treated with either currently available sirolimus or paclitaxel coated DCBs (see Table 1), irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. Outcomes will be compared in different clinical subgroups. The impact of current DCBs in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.",[63,64,65,66,67,68,69,70,28,71],{"date":74,"type":40},{"date":94,"type":40},"2021-06-01",{"date":78,"type":20},{"name":80,"class":47}]