[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624652":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":25,"responsibleParty":37,"collaborators":10,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":10,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":10,"enrollmentInfo":49,"targetDuration":10,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"I.M. Sechenov First Moscow State Medical University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Training sample",null,"300 patients 18 years old and older with and without pulmonary embolism confirmed by the results of full examination (laboratory, clinical and instrumental) and by results of the spectral analysis of electrocardiogram (the parameters listed below will be calculated as the median of the tact-cycle: TpTe, VAT, QTc, QT \u002F TQ, QRS\\_E, T\\_E, TP\\_E, BETA, BETA\\_S, BAD\\_T, QRS\\_D1\\_ons, QRS\\_D1\\_offs, QRS\\_D2, QRS\\_Ei (i = 1,2,3,4), T\\_Ei (i= 1,2,3,4), HFQRS, QRSw, RA, SA, TA and others).",{"label":13,"type":10,"description":14,"interventionNames":10},"Test sample","200 patients 18 years old and older with and without pulmonary embolism confirmed by the results of full examination (laboratory, clinical and instrumental) and by results of the spectral analysis of electrocardiogram (the parameters listed below will be calculated as the median of the tact-cycle: TpTe, VAT, QTc, QT \u002F TQ, QRS\\_E, T\\_E, TP\\_E, BETA, BETA\\_S, BAD\\_T, QRS\\_D1\\_ons, QRS\\_D1\\_offs, QRS\\_D2, QRS\\_Ei (i = 1,2,3,4), T\\_Ei (i= 1,2,3,4), HFQRS, QRSw, RA, SA, TA and others).",[16,21],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Petr Chomakhidze, Professor","CONTACT","+79166740369","chomakhidze_p_sh@staff.sechenov.ru",{"name":22,"role":18,"phone":23,"phoneExt":10,"email":24},"Aliya Khusyainova, Dr.","+79832824402","khusyainova1997@bk.ru",[26],{"facility":27,"status":10,"city":28,"state":10,"zip":10,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":10},"University Clinical Hospital №1, Sechenov University","Moscow","Russia","RU",{"type":32,"coordinates":33},"Point",[34,35],37.61781,55.75204,{"lat":35,"lon":34},{"type":38,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100624652","screening-for-pulmonary-embolism-using-single-channel-electrocardiogram-100624652",false,"NCT07412418","Screening for Pulmonary Embolism Using Single-channel Electrocardiogram","Screening for Pulmonary Embolism Using Single-channel Electrocardiogram Data Using Machine Learning Models","Inclusion Criteria:\n\n1. A clinical condition requiring exclusion of acute pulmonary embolism;\n2. The presence of written informed consent of the patient to participate in the study;\n3. Age from 18 years old and older\n\nNon-inclusion criteria:\n\n1. Refusal to undergo examination or the inability to reliably verify or exclude the diagnosis of pulmonary embolism;\n2. Treatment, in particular anticoagulant therapy, before recording a single-lead ECG;\n3. Conditions in which recording an ECG in lead I is not possible (congenital anomalies of the upper limbs, traumatic amputation of the upper limbs, tremor, etc.);\n4. Refusal to sign written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Poor ECG quality, preventing the necessary analysis of a single-channel ECG;\n2. Incomplete examination, preventing a reliable determination of the presence or absence of pulmonary embolism;\n3. Refusal to further participate in the study.",true,"ALL","18 Years",{"count":50,"type":51},500,"ESTIMATED","OBSERVATIONAL","It is a prospective, controlled, single-center, observational, non-randomized study. The study is planned to include at least 500 patients 18 years old and older (300 patients in the training sample and 200 patients in the test sample.\n\nThe study will include all patients requiring exclusion of the diagnosis of acute pulmonary embolism. Patients will be examined according to clinical guidelines to confirm the diagnosis of pulmonary embolism (laboratory, clinical and instrumental).\n\nDuring the course of the study, the authors of the work do not interfere with the scope of the examination, which is caried out on patients in accordance with clinical guidelines.\n\nAll patients included in the study will undergo electrocardiogramm (ECG) in standart lead I for 1 minute, followed by spectral analysis of the obtained data, which will be stored at the Remote monitoring center of Sechenov University without being linked to the personal data of patients. A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transformation. The result of this study will be the identification of ECG parameters that will correlate with pulmonary embolism.",[55,56,57],"Pulmonary Embolism (Diagnosis)","Respiratory Failure With Hypoxia","Chronic Obstructive Pulmonary Disease (COPD)",[59,60,61,62,63,64],"Screening","single-channel electrocardiogram","machine learning models","pulmonary embolism","respiratory failure","chronic obstructive pulmonary disease","NOT_YET_RECRUITING","2026-04-30",{"date":68,"type":69},"2026-05-01","ACTUAL",{"date":68,"type":51},{"date":72,"type":51},"2028-07-30",{"name":5,"class":6},1]