Screening for Pulmonary Embolism Using Single-channel Electrocardiogram (NCT07412418) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Screening for Pulmonary Embolism Using Single-channel Electrocardiogram
Russia500 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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.
. Poor ECG quality, preventing the necessary analysis of a single-channel ECG;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determination of sensitivity of pulmonary embolism of multivariate models for analyzing single-channel electrocardiogram data
Timeframe: through study completion, an average of 2 years
2
Parameters of single-channel ECG that significantly correlate with the presence of pulmonary embolism;
Timeframe: through study completion, an average of 2 years
3
Determination of specificity of pulmonary embolism of multivariate models for analyzing single-channel electrocardiogram data
Timeframe: 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
Timeframe: through study completion, an average of 2 years
Trial details
NCT IDNCT07412418
SponsorI.M. Sechenov First Moscow State Medical University