[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06753045":3,"trial-entities:NCT06753045":122,"trial-summary:NCT06753045":132},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":35,"interventions":38,"primary_outcomes":45,"secondary_outcomes":53,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":75,"locations":78,"central_contacts":115,"overall_officials":118,"references":120,"see_also_links":121},"NCT06753045","2024-652","Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology","Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology: HEARTBEAT","RECRUITING","2027-10","2026-03","2026-03-05","2024-10-08","Tulane University","OTHER",false,"This is a phase 0, non-interventional, longitudinal, electronic data capture (EDC) study to facilitate the HEARTBEAT Study project has set out to explore the potential use of smartwatches in collecting and analyzing biometric data to improve the detection, identification, and understanding of cardiovascular diseases and related conditions by SAMSUNG and Tulane. The study will include up to ten thousand adult subjects tasked with wearing a smartwatch to collect digital biomarker data over a 1 year period. Concurrent to smartwatch data collection, subjects will be instructed to complete questionnaires via the Huma Decentralized Clinical Trials (HUMADCT) platform. There are no investigational drugs or interventions administered as part of this study.","The central hypothesis in the HEARTBEAT project posits that cardiovascular events are preceded by abnormalities in biometric signals obtained from a smartwatch. These abnormalities may include, but are not limited to, patterns of heart rate, heart rate variability, oxygen saturation, as well as raw PPG signals. By leveraging advanced analytics and machine learning algorithms on smartwatch-derived biometric data, the investigators plan to identify patterns and markers that signal an increased cardiovascular disease risk.\n\nThe study will use an end-to-end decentralized approach for data collection. Huma and Alcedis, the electronic data capture (EDC) agencies, will act as the data storage facilitator for 10,000 eligible subjects. The Principal Investigators (PIs) and trained site staff members will assess healthy subjects based on their clinical opinion. If the subjects meet the eligibility criteria and are interested in participating, they will be consented by Tulane.\n\nDuring the study enrollment phase, a smartwatch will be provided to the subjects, who will then be trained on the study procedures, the web-based questionnaire, and the use of the wearable device. The subjects will be asked to wear the device for one year, after which they will return it to Tulane.",[19],"Heart Diseases",[21,22,23,24,25,26,27,28,29,30,31],"Heart failure","Coronary artery disease","Stroke\u002FTIA","Diabetes mellitus","Chronic kidney disease","Cardiac arrhythmias","Smart watch","Atrial fibrillation","A-fib","Artificial intelligence","Machine learning","OBSERVATIONAL",null,[],{"count":36,"type":37},10000,"ESTIMATED",[39],{"type":14,"name":40,"description":41,"armGroupLabels":42},"Smartwatch","Sensors on the smartwatch will measure vitals such as heart rate, blood pressure, oxygen saturation, body composition, and electrocardio gram (ECG)",[43,44],"Cohort arm","Healthy arm",[46,50],{"measure":47,"description":48,"timeFrame":49},"The incidence of cardiovascular events indicative of progression of pre-existing cardiovascular conditions","These endpoints will be collected from the electronic health records using the International Classification of Diseases Tenth Edition (ICD-10) codes, prompted by a patient survey conducted via the use of a smart phone app. The investigators will use the the patient's survey answers as a prompt to check the EMR. If in the survey a patient mentions they had a cardiovascular incidence, then the EMR data will be checked to see the reports from the ER visit to confirm the incidence. The number that will be reported is the total number of cardiovascular incidences in each patient over the period of 1 year.","1 Year",{"measure":51,"description":52,"timeFrame":49},"The incidence of new cardiovascular diseases events","These endpoints will be collected from the electronic health records using the International Classification of Diseases Tenth Edition (ICD-10) codes, prompted by a patient survey conducted via the use of a smart phone app. The investigators will use the the patient's survey answers as a prompt to check the EMR. If in the survey a patient mentions they had a cardiovascular incidence, then the EMR data will be checked to see the reports from the ER visit to confirm the incidence and check to confirm if the patient developed a new cardiovascular disease. The number that will be reported is the total number of cardiovascular incidences in each patient over the period of 1 year.",[],"ALL","18 Years","120 Years",true,{"inclusion":59,"exclusion":62,"raw_text":74},[60,61],"Patients with at least one cardiovascular disease (heart failure, cardiac arrhythmias, chronic kidney disease, coronary artery disease, history of stroke\u002FTransient Ischemic Attack (TIA), or diabetes mellitus).","Patients visiting a primary care provider for any reason without any of the previously mentioned cardiovascular diseases. (Healthy cohort, limited up to 500 patients throughout the study).",[63,64,65,66,67,68,69,70,71,72,73],"Participants who cannot read, speak, and\u002For understand English.","Participants with cognitive impairments who are unable to give informed consent or sign their HIPAA form.","Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices.","Participants who are pregnant.","Participants with tattoos, scars, or skin adhesions that would not allow for Photoplethysmography (PPG) recordings to be collected from a wrist-worn device.","Participants with neurological disorders that may interfere with device signal quality (e.g., hand tremors).","Participants with a pacemaker.","Participants with allergies to watch and\u002For wristband materials.","Participants with known plans to permanently leave the state of Louisiana within the observational period.","Participants who have no known medical history with any of the enrolling institutions.","Patients without a compatible smartphone (iOS 13 \\& Android 11 at minimum).","Inclusion Criteria:\n\n* Patients with at least one cardiovascular disease (heart failure, cardiac arrhythmias, chronic kidney disease, coronary artery disease, history of stroke\u002FTransient Ischemic Attack (TIA), or diabetes mellitus).\n* Patients visiting a primary care provider for any reason without any of the previously mentioned cardiovascular diseases. (Healthy cohort, limited up to 500 patients throughout the study).\n\nExclusion Criteria:\n\n* Participants who cannot read, speak, and\u002For understand English.\n* Participants with cognitive impairments who are unable to give informed consent or sign their HIPAA form.\n* Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices.\n* Participants who are pregnant.\n* Participants with tattoos, scars, or skin adhesions that would not allow for Photoplethysmography (PPG) recordings to be collected from a wrist-worn device.\n* Participants with neurological disorders that may interfere with device signal quality (e.g., hand tremors).\n* Participants with a pacemaker.\n* Participants with allergies to watch and\u002For wristband materials.\n* Participants with known plans to permanently leave the state of Louisiana within the observational period.\n* Participants who have no known medical history with any of the enrolling institutions.\n* Patients without a compatible smartphone (iOS 13 \\& Android 11 at minimum).",[76,77],"ADULT","OLDER_ADULT",[79,100,108],{"facility":80,"status":8,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":97},"East Jefferson General Hospital","New Orleans","Louisiana","70006","United States",[86,91,94],{"name":87,"role":88,"phone":89,"email":90},"Kunal Sameer, MD, MHA","CONTACT","504-988-3058","heartbeat@tulane.edu",{"name":92,"role":88,"phone":89,"email":93},"Page E McKenzie, MS","pmckenzie@tulane.edu",{"name":95,"role":96},"Nassir Marrouche, MD","PRINCIPAL_INVESTIGATOR",{"lat":98,"lon":99},29.95465,-90.07507,{"facility":101,"status":8,"city":81,"state":82,"zip":102,"country":84,"contacts":103,"geoPoint":107},"Tulane University Medical Group Clinics","70112",[104,105,106],{"name":87,"role":88,"phone":89,"email":90},{"name":92,"role":88,"phone":89,"email":93},{"name":95,"role":96},{"lat":98,"lon":99},{"facility":109,"status":8,"city":81,"state":82,"zip":102,"country":84,"contacts":110,"geoPoint":114},"University Medical Center",[111,112,113],{"name":87,"role":88,"phone":89,"email":90},{"name":92,"role":88,"phone":89,"email":93},{"name":95,"role":96},{"lat":98,"lon":99},[116,117],{"name":87,"role":88,"phone":89,"email":90},{"name":92,"role":88,"phone":89,"email":93},[119],{"name":95,"affiliation":13,"role":96},[],[],{"nct_id":4,"conditions":123,"biomarkers":131},[124,125,126,127,128,129,130],"Arrhythmia","Chronic Kidney Disease","Coronary Artery Disease","Diabetes Mellitus","Heart Failure","Stroke","Transient Ischemic Attack",[],{"nct_id":4,"found":57,"summary":133,"prompt_version":143},{"design":134,"status":135,"heading":136,"summary":137,"follow_up":138,"word_count":139,"commitments":140,"compensation":141,"drugs_mentioned":142},"This is an observational study with a planned enrollment of 10,000 adult participants. It is designed to collect data over a one-year period using smartwatches.","completed","Observational Study of Smartwatches for Heart Disease Detection","This study, called HEARTBEAT, is looking at how smartwatches can help us understand and detect heart diseases better. Researchers want to see if the information collected by smartwatches, like your heart rate and blood pressure, can show early signs of heart problems. You could join if you are an adult (18-120 years old) and either have a heart condition (like heart failure or diabetes) or are visiting a primary care doctor for any reason. The study will provide you with a smartwatch to wear for one year. The main goal is to see how often people experience new or worsening heart problems during that year, and if the smartwatch data can predict these events. This is an observational study, meaning there are no experimental drugs or treatments given.","Participants will be followed for one year to track cardiovascular events.",128,"You would wear a provided smartwatch for one year and complete questionnaires using a digital platform. You will be trained on how to use the device and platform.","Not stated in the trial record.",[40],"v2"]