Screening for Pulmonary Embolism Using Single-channel Electrocardiogram

NCT07412418 | Not Yet Recruiting

• 1 other identifier: ChPSH2226
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism (Diagnosis); Respiratory Failure With Hypoxia; Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Screening; single-channel electrocardiogram; machine learning models; pulmonary embolism; respiratory failure; chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (4)

• 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

  through study completion, an average of 2 years

• 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

  through study completion, an average of 2 years

• 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

  through study completion, an average of 2 years

• 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

  through study completion, an average of 2 years

Study Arms (2)

Training sample

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 / 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).

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 / 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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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;
• Treatment, in particular anticoagulant therapy, before recording a single-lead ECG;
• 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.);
• Refusal to sign written informed consent to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

University Clinical Hospital №1, Sechenov University

Moscow, Russia

Location

MeSH Terms

Conditions

Pulmonary Embolism; Disease; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Respiration Disorders

Central Study Contacts

Petr Chomakhidze, Professor

CONTACT

+79166740369; chomakhidze_p_sh@staff.sechenov.ru

Aliya Khusyainova, Dr.

CONTACT

+79832824402; khusyainova1997@bk.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)