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It is a prospective, controlled, single-center, non-randomized, observational study.
From September 2019 to December 2020, the study plans to prospectively include 400 patients aged 18 to 90 years.
Every patients will undergo an echocardiographic examination with assessment diastolic dysfunction of the left ventricle, and registration of an electrocardiogram using a single lead ECG monitor CardioQvark (in I standard lead) for 3 minutes. All patients will be divided into 2 main groups: with diastolic dysfunction of the left ventricle, confirmed by the results of the echocardiography and without. A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform.
The result of this study will be the identification of ECG parameters that will correlate with LV diastolic dysfunction.
It is a prospective, controlled, single-center, non-randomized, observational study.
From September 2019 to December 2020, the study plans to prospectively include 400 patients aged 18 to 90 years.
The goal of study is reveal single parameters of the electrocardiogram, which a good correlation with left ventricular diastolic dysfunction (LV DD), discovered during echocardiography.
Investigators plan to assess the diagnostic effectiveness of the spectral analysis of electrocardiograms obtained using a single-lead portable ECG monitor.
All subjects will undergo an echocardiographic examination of the heart with a determination of diastolic dysfunction of the left ventricle and will be divided into 2 main groups: with diastolic dysfunction of the left ventricle, confirmed by the results of the echocardiography and without.
At the same time, for all patients single-lead ECG will be recorded (in turn of leads I) for 3 minutes with further spectral analysis of the data obtained.
A single-lead ECG monitor CardioQvark is designed as an iPhone cover. It is registered with the Federal Service for Health Supervision on February 15, 2019. RZN No. 2019/8124.
Then a spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform, the principles of which are based on the Fourier transform.
The analysis implies an assessment of the following parameters (the parameters listed below will be calculated as the median of the tact-cycle):
Additionally used parameters:
Statistical processing of results: SPSS Statistics Version 26 is a computer program for statistical processing of data.
The result of this study will be the identification of ECG parameters that will correlate with LV diastolic dysfunction, and by which it will be possible to determine its presence and degree in the future.
Investigators also plan to analyze ECG parameters characteristic of patients with LV diastolic dysfunction in different population groups:
During statistical processing of the data, the following will be calculated: sensitivity, specificity, prognostic value of positive and negative results, likelihood ratio, area under ROC - curve, correlation coefficient. it is planned to obtain data on the diagnostic effectiveness of the proposed approach, as well as on individual parameters of the electrocardiogram in the diagnosis of diastolic dysfunction of the left ventricle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with diastolic dysfunction | patients with diastolic dysfunction of the left ventricle confirmed by the results of the echocardiography (septal e' >=8, and lateral e'>=10 and left atrium <34 ml/m2) 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). |
| |
| without diastolic dysfunction | patients without diastolic dysfunction of the left ventricle confirmed by the results of the echocardiography (septal e'<8, and lateral e'<10 and left atrium >=34 ml/m2) 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| echocardiographic examination | Device | conducting an echocardiographic study according to a standard protocol with the determination of diastolic dysfunction of the left ventricle |
| Measure | Description | Time Frame |
|---|---|---|
| determination of sensitivity of LV DD using a single-channel ECG monitor CardioQvark | comparison of the presence of LV DD detected by the results of an echocardiographic study with the results of the presence of LV DD obtained using the mathematical model of a single-channel ECG of the CardioQvark monitor | through study completion, an average of 2 years |
| determination of specificity of LV DD using a single-channel ECG monitor CardioQvark | comparison of the presence of LV DD detected by the results of an echocardiographic study with the results of the presence of LV DD obtained using the mathematical model of a single-channel ECG of the CardioQvark monitor | through study completion, an average of 2 years |
| determination of prognostic value of positive and negative results of LV DD using a single-channel ECG monitor CardioQvark | comparison of the presence of LV DD detected by the results of an echocardiographic study with the results of the presence of LV DD obtained using the mathematical model of a single-channel ECG of the CardioQvark monitor | through study completion, an average of 2 years |
| determination of likelihood ratio of LV DD using a single-channel ECG monitor CardioQvark | comparison of the presence of LV DD detected by the results of an echocardiographic study with the results of the presence of LV DD obtained using the mathematical model of a single-channel ECG of the CardioQvark monitor | through study completion, an average of 2 years |
| determination of area under ROC - curve of LV DD using a single-channel ECG monitor CardioQvark | comparison of the presence of LV DD detected by the results of an echocardiographic study with the results of the presence of LV DD obtained using the mathematical model of a single-channel ECG of the CardioQvark monitor |
| Measure | Description | Time Frame |
|---|---|---|
| significance of the parameter TpTe on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter VAT on the ECG in the determination of LV DD |
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Inclusion Criteria:
Exclusion Criteria:
Non-inclusion criteria:
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all patients aged 18 to 90 years
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| Name | Affiliation | Role |
|---|---|---|
| Philipp Kopylov | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Study Director |
| Natalia Kuznetsova | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.M. Sechenov First Moscow State Medical University (Sechenov University) | Moscow | Russia |
It is not possible to provide documentation due to the prohibition received from the local ethics committee
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| through study completion, an average of 2 years |
| determination of correlation coefficient of LV DD using a single-channel ECG monitor CardioQvark | comparison of the presence of LV DD detected by the results of an echocardiographic study with the results of the presence of LV DD obtained using the mathematical model of a single-channel ECG of the CardioQvark monitor | through study completion, an average of 2 years |
an ECG spectral analysis will be performed using the Fourier Transform |
| through study completion, an average of 2 years |
| significance of the parameter QTc on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter QT / TQ on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter QRS_E on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter T_E on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter TP_E on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter BETA on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter BETA_S on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter BAD_T on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter QRS_D1_ons on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter QRS_D1_offs on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter QRS_D2 on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter QRS_Ei on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter T_Ei on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter HFQRS on the ECG in the determination of LV DD | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |