Not_yet_recruitingNCT07412418

Screening for Pulmonary Embolism Using Single-channel Electrocardiogram Data Using Machine Learning Models

Sponsor: I.M. Sechenov First Moscow State Medical University

Trial Details

ConditionPulmonary Embolism (Diagnosis), Respiratory Failure With Hypoxia, Chronic Obstructive Pulmonary Disease (COPD)
StatusNot_yet_recruiting
Participants500
Est. Completion30 Mar 2028
Last Updated1 May 2026

Primary Outcome

Determination of sensitivity of pulmonary embolism of multivariate models for analyzing single-channel electrocardiogram data; Parameters of single-channel ECG that significantly correlate with the presence of pulmonary embolism;; Determination of specificity of pulmonary embolism of multivariate models for analyzing single-channel electrocardiogram data; Determination of diagnostic accuracy of pulmonary embolism of multivariate models for analyzing single-channel electrocardiogram data

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: 1. A clinical condition requiring exclusion of acute pulmonary embolism; 2. The presence of written informed consent of the patient to participate in the study; 3. Age from 18 years old and older Non-inclusion criteria: 1. Refusal to undergo examination or the inability to reliably verify or exclude the diagnosis of pulmonary embolism; 2. Treatment, in particular anticoagulant therapy, before recording a single-lead ECG; 3. 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.); 4. Refusal to sign written informed consent to participate in the study. Exclusion Criteria: 1. Poor ECG quality, preventing the necessary analysis of a single-channel ECG; 2. Incomplete examination, preventing a reliable determination of the presence or absence of pulmonary embolism; 3. Refusal to further participate in the study.

Trial Sites

Countries

Russia
View Registry Entry

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