[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04336644":3,"trial-entities:NCT04336644":96,"trial-summary:NCT04336644":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":16,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":62,"locations":65,"central_contacts":86,"overall_officials":89,"references":91,"see_also_links":92},"NCT04336644","202001147","Continuous Versus Intermittent cARdiac Electrical moNitorinG","RECRUITING","2026-12-31","2025-12","2025-12-30","2023-11-21","Washington University School of Medicine","OTHER",true,"The purpose of this study is to validate the continuous patch monitoring system to evaluate cardiac arrhythmias in patients receiving drugs that can cause cardiac complications and compare the continuous patch system with standard electrocardiograms (ECGs).",null,[18,19],"Torsades de Pointe Caused by Drug","Long QT Syndrome",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"NA",{"count":26,"type":27},60,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DEVICE","BodyGuardian Mini Plus","The BodyGuardian Mini Plus attaches to the upper chest of the patient through the use of an adhesive patch. ECG tracings are recorded continuously and sent to the linked smartphone and subsequently to a cloud server.",[34],"Continuous patch monitoring system",[34],[37,41,44],{"measure":38,"description":39,"timeFrame":40},"Comparison of blinded, manual measurements of the ECGs to the patch monitor tracings as measured by the Bland-Altman Plot","* The Bland Altman plot provides a graphical method to compare the question of interest, namely that the measurements derived from the patch monitor are accurate in relation to the gold standard of the ECG.\n* Each QT measured from the tracing will be plotted against the difference in QT between the tracing and the 12-lead ECG. The acceptable difference between measurement techniques will be set at 5 ms (primary, strict threshold based on FDA recommendations) with a clinically acceptable difference of 15 ms (based on known variability in 12-lead ECG recordings).","Through Day 30",{"measure":42,"description":43,"timeFrame":40},"Frequency of major arrhythmia occurrence","* The QT interval will be assessed every 4 hours for the first 5 days and then every 8 hours thereafter",{"measure":45,"description":46,"timeFrame":47},"Trajectories of QT prolongation","* Will assess the QT interval every four hours for five days after drug initiation and after five days, the QTc will be assessed every 8 hours\n* With this data, the investigators will plot the QTc interval (Fridericia correction) over time and determine the time of expected peak effect. Outliers will be reviewed and verified manually.","Through day 30",[],"ALL","18 Years",false,{"inclusion":53,"exclusion":58,"raw_text":61},[54,55,56,57],"Diagnosis of acute promyelocytic leukemia (APL) and being initiated on standard of care arsenic trioxide OR Diagnosis of solid tumor and being initiated on standard of care capecitabine (alone or as part of combination treatment) OR Diagnosis of solid tumor and being initiated on standard of care ribociclib (alone or as part of combination treatment)","At least 18 years of age.","No allergy to adhesive patches.","Able to understand and willing to sign an IRB-approved written informed consent document.",[59,60],"Younger than 18 years of age","Allergy to adhesive patches","Inclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia (APL) and being initiated on standard of care arsenic trioxide OR Diagnosis of solid tumor and being initiated on standard of care capecitabine (alone or as part of combination treatment) OR Diagnosis of solid tumor and being initiated on standard of care ribociclib (alone or as part of combination treatment)\n* At least 18 years of age.\n* No allergy to adhesive patches.\n* Able to understand and willing to sign an IRB-approved written informed consent document.\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Allergy to adhesive patches",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":12,"status":7,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":83},"St Louis","Missouri","63110","United States",[72,77,81],{"name":73,"role":74,"phone":75,"email":76},"Joshua D Mitchell, M.D., FACC","CONTACT","314-494-3124","jdmitchell@wustl.edu",{"name":78,"role":74,"phone":79,"email":80},"Kaitlin Moore","314-273-0830","kaitlin.m.moore@wustl.edu",{"name":73,"role":82},"PRINCIPAL_INVESTIGATOR",{"lat":84,"lon":85},38.62727,-90.19789,[87,88],{"name":73,"role":74,"phone":75,"email":76},{"name":78,"role":74,"phone":79,"email":80},[90],{"name":73,"affiliation":12,"role":82},[],[93],{"label":94,"url":95},"Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine","http:\u002F\u002Fwww.siteman.wustl.edu",{"nct_id":4,"conditions":97,"biomarkers":100},[98,99],"Acute Promyelocytic Leukemia","Solid Neoplasm",[],{"nct_id":4,"found":14,"summary":102,"prompt_version":112},{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study with a planned enrollment of 60 participants. It aims to compare the BodyGuardian Mini Plus device with standard electrocardiograms.","completed","Continuous Cardiac Monitoring for Drug-Induced Heart Complications","This study is testing a continuous heart monitoring system called BodyGuardian Mini Plus. This device attaches to your chest and continuously records your heart's electrical activity (ECG tracings). The goal is to see how well this system compares to standard ECGs in detecting heart rhythm problems like Torsades de Pointe (a type of irregular heartbeat) and Long QT Syndrome (a heart condition that can cause fast, chaotic heartbeats). You might be able to join if you are at least 18 years old and are starting treatment for acute promyelocytic leukemia with arsenic trioxide, or a solid tumor with capecitabine or ribociclib. The study is looking at how often major arrhythmias happen and changes in QT prolongation over 30 days. The current status of this study is unclear.","Your heart activity will be monitored and evaluated for up to 30 days after starting the study.",127,"You would wear the BodyGuardian Mini Plus device, which records your heart's electrical activity continuously for up to 30 days.","Not stated in the trial record.",[31],"v2"]