Screening for Pulmonary Embolism Using Single-channel Electrocardiogram

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.M. Sechenov First Moscow State Medical University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 2 trial groups
Group A: Training sample
Group B: Test sample

Trial outcomes

Primary outcomes

1

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

Time frame
through study completion, an average of 2 years
2

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

Time frame
through study completion, an average of 2 years
3

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

Time frame
through study completion, an average of 2 years
4

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

Time frame
through study completion, an average of 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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