About this trial
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.
The 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).
During 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.
All 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
A clinical condition requiring exclusion of acute pulmonary embolism;
The presence of written informed consent of the patient to participate in the study;
Age from 18 years old and older
Refusal to undergo examination or the inability to reliably verify or exclude the diagnosis of pulmonary embolism;
Disqualifiers
Poor ECG quality, preventing the necessary analysis of a single-channel ECG;
Incomplete examination, preventing a reliable determination of the presence or absence of pulmonary embolism;
Refusal to further participate in the study.
Trial population
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. The 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). During 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
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Determination of sensitivity of pulmonary embolism of multivariate models for analyzing single-channel electrocardiogram data
comparison of the presence of pulmonary embolism by the results of full examination (laboratory, clinical and instrumental) with the results of the presence of pulmonary embolism obtained using the mathematical model of a single-channel ECG monitor
Parameters of single-channel ECG that significantly correlate with the presence of pulmonary embolism;
comparison of the presence of pulmonary embolism by the results of full examination (laboratory, clinical and instrumental) with the results of the presence of pulmonary embolism obtained using the mathematical model of a single-channel ECG monitor
Determination of specificity of pulmonary embolism of multivariate models for analyzing single-channel electrocardiogram data
comparison of the presence of pulmonary embolism by the results of full examination (laboratory, clinical and instrumental) with the results of the presence of pulmonary embolism obtained using the mathematical model of a single-channel ECG monitor
Determination of diagnostic accuracy of pulmonary embolism of multivariate models for analyzing single-channel electrocardiogram data
comparison of the presence of pulmonary embolism by the results of full examination (laboratory, clinical and instrumental) with the results of the presence of pulmonary embolism obtained using the mathematical model of a single-channel ECG monitor
Sponsors and contacts
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