HypertensionNCT04788342
Pulse Wave Parameters in the Assessment of Systolic Function of the Left Ventricle.
An observational study of Hypertension and Heart Failure, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
This is a prospective, single-center, non-randomized, observational study. The aim of this study is to determine the potential of a single-lead electrocardiogram monitor CardioQvark with photoplethysmography function use to evaluate systolic function of the left ventricle. The study is conducted in the clinic of I.M. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Heart Failure
- What is being tested?
- pulse wave recording, echocardiography.
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2019to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with different pathologies of the cardiovascular system (coronary artery disease, hypertension, valvular heart disease, heart failure) aged 18 years and older.
Who may be able to join
- The presence of written informed consent of the patient to participate in the study.
- The presence of diagnosed cardiac pathology according anamnesis (coronary artery disease (I-IV classes according Canadian Cardiovascular Society grading of angina pectoris, post myocardial infarction, patients after percutaneous coronary intervention or coronary artery bypass grafting); hypertension (stages I- III); valvular heart disease (except patients with aortic valve stenosis and mechanical prosthetic heart valve); heart failure (I-IV NYHA).
- -
Who cannot join
- 1. Patient's reluctance to participate in the study. 2. Poor quality of ECG recording by a single-channel ECG monitor. 3. Poor visualization of the heart during echocardiography.
- -
- Non-inclusion criteria:
- The presence of rhythm and conduction disorders (WPW syndrome, frequent premature ventricular complexes, 2nd and 3rd degree sinoatrial block, 3rd degree atrioventricular block, complete left bundle branch block, complete right bundle branch block).
- Patients with permanent cardiac pacemaker, cardio-resynchronization therapy (CRT), implantable cardioverter-defibrillator (ICD).
- Conditions that can impair ECG recording quality (Parkinson's disease, essential tremor, etc.) or conditions that make it difficult to record ECG and photoplethysmogram (traumatic arm amputation)
Show all 9Show fewer
- Mental illness (diagnosed early)
- Diseases with a life expected expectancy of less than 2 years.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Russia1 site
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow
About this study
Official title: Pulse Wave Parameters Registered by a Single-lead Electrocardiogram Monitor With Photoplethysmography Function in the Assessment of Systolic Function of the Left Ventricle.
This is a prospective, single-center, non-randomized, observational study. The aim of this study is to determine the potential of a single-lead electrocardiogram monitor CardioQvark with photoplethysmography function use to evaluate systolic function of the left ventricle.
The study is conducted in the clinic of I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia. It is planned to include 400 patients. Recording of the electrocardiogram and photoplethysmogram by the monitor CardioQvark and the assessment of systolic function using echocardiography will be performed in all study participants.
The result of this study will be the identification of the parameters of the pulse wave and electrocardiogram that will correlate with systolic function of the left ventricle. It is also planned to determine the diagnostic effectiveness of this method.
Read the detailed description
The aim of this study is to determine the potential of a single-lead electrocardiogram (ECG) monitor CardioQvark (Moscow, Russia) with photoplethysmography function use to evaluate parameters systolic function of the left ventricle. Also according to the photoplethysmogram (PPG), using a special algorithm, the levels of systolic and diastolic blood pressure are calculated.
The single-lead electrocardiogram monitor CardioQvark (it is registered with the Federal Service for Health Supervision on February 15, 2019. RZN (Roszdravnadzor) No. 2019/8124) looks like an iPhone cover and records electrocardiogram (I standard lead) and photoplethysmogram (pulse wave) simultaneously.
This is a prospective, single-center, non-randomized, observational study. The investigators are planning to include in the study 400 patients with different pathologies of the cardiovascular system (coronary artery disease, hypertension, valvular heart disease, heart failure) according to the inclusion criteria.
Collection of medical history; physical examination (including inspection, palpation and auscultation, as well as determination of breathing rate, pulse rate, height, and weight) will be performed for the entire group of patients. Electrocardiogram and photoplethysmogram registration and assessment of the blood pressure using a CardioQvark monitor will be performed on all study participants at rest (the patient will sit quietly for 10-15 minutes before the examination). The reference blood pressure will be measured using a cuff-based blood pressure device ("Microlife BP AG1-10") that is worn on the upper arm according to the World Health Organization recommendations.
All subjects will undergo an echocardiography ("Dimension/Vivid 7 PRO General Electric Medical System"), the examination will be performed by an experienced doctor (the doctor will not have data on the parameters of the pulse wave and electrocardiogram). The extended protocol echocardiography will be performed according to the recommendations of European Association of Cardiovascular Imaging (EACVI) and American Society of Echocardiography (ASE). All examinations will be performed consistently within one day.
All electrocardiograms and photoplethysmograms records will be sent to the CardioQVARK server and processed by the algorithm using signal processing based on the wavelet transformation. Then engineers of "CardioQvark" (Limited Liability Company) will calculate the pulse wave parameters:
- B1 is the beginning of the wave
- B0 is the point of maximum increase of the anterior front
- SEP is the peak of the ejected pulse wave
- DER3 is the first positive peak of the third derivative
- SEPMAX is the point of the first inflection of pulse wave
- SRP is the peak of the reflected systolic wave
- DP is the peak of the diastolic wave
- End is the end of the wave
- perfusion index
- augmentation index.
A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform, the principles of which are based on the Fourier transform:
- TpTe - time from peak to end of the T-wave
- VAT - time from the beginning of the QRS to the R-peak
- QTc - corrected QT interval.
- QT / TQ - the ratio of QT length to TQ length (from the end of T to the beginning of the QRS of the next complex).
- QRS_E - the total energy of the QRS wave based on the wavelet transform
- T_E - T-wave total energy based on wavelet transform
- TP_E- energy of the main tooth of the T-wave based on the wavelet transform
- BETA, BETA_S - T-wave asymmetry coefficients (simple and smooth versions)
- BAD_T - flag of T-wave quality (whether expressed in the current lead
- QRS_D1_ons - energy of the leading edge of the R-wave (based on the "first derivative" wavelet transform)
- QRS_D1_offs - energy of the trailing edge of the R-wave (based on the "first derivative" wavelet transform)
- QRS_D2 - peak energy of the R-wave (based on the "second derivative" wavelet transform)
- QRS_Ei (i = 1,2,3,4) - QRS-wave energy in 4 frequency ranges (2-4-8-16-32 Hz) based on wavelet transform
- T_Ei (i = 1,2,3,4) - T-wave energy in 4 frequency ranges (2-4-6-8-10 Hz) based on wavelet transform
- HFQRS - the amplitude of the RF components of the QRS wave. The engineers will not have echocardiography results.
The investigators will evaluate parameters of the pulse wave (photoplethysmogram) and electrocardiogram and compare the results with echocardiography (ejection fraction, left ventricular outflow tract velocity time integral (VTI), left ventricular global longitudinal strain (GLS)).The mathematical model for determining the systolic dysfunction of the left ventricle will be built on the basis of the parameters of the photoplethysmogram and the electrocardiogram.
Intergroup analysis of significant differences, correlation analysis and Bland-Altman method will be used for statistical data analysis. All statistical analyses will be perform using a computer program for statistical processing of data SPPS (statistical package for the social sciences) Statistics Version 26.
It is planned to obtain comparative characteristics of the pulse wave and electrocardiogram parameters registered by the CardioQvark monitor and the indicators of systolic function of the left ventricle detected during echocardiography. The result of this study will be the identification of the parameters of the pulse wave and electrocardiogram that will correlate with systolic dysfunction of the left ventricle. It is planned to determine the diagnostic effectiveness of this method. The accuracy of the blood pressure measurement using the CardioQvark monitor will also be evaluated.
Thus, a quick and convenient assessment of systolic function of the left ventricle and blood pressure measurement will be available. So, study results will improve the diagnosis and treatment of cardiovascular disease.
- Conditions
- Hypertension, Heart Failure
- Being tested
- pulse wave recording, echocardiography.
- Keywords
- pulse wave, systolic function of the left ventricle, ejection fraction, blood pressure, a single-lead electrocardiogram, remote determination of the systolic function
- Medical subject headings
- Hypertension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulse wave recording, echocardiography.Device
Also called blood pressure measurement
pulse wave recording using a single-channel electrocardiogram cardiomonitor with photoplethysmography, conducting echocardiography according to a standard protocol with the determination of systolic function of the left ventricle
| Study group | Role | What they receive |
|---|---|---|
| Patients with and without left ventricular systolic dysfunction | Patients with different pathologies of the cardiovascular system (coronary artery disease, hypertension, valvular heart disease, heart failure) will be performed pulse wave recording using a CardioQvark cardiomonitor and echocardiography. Receives: Device: pulse wave recording, echocardiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the comparative characteristics of the pulse wave parameters registered by a single- lead ECG monitor CardioQvark and indicators of systolic function of the left ventricle detected during echocardiography.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
Measured: Through study completion, an average of 1 year.
Diagnostic accuracy of the pulse wave and electrocardiogram parameters registered by a single- lead ECG monitor CardioQvark.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
Measured: Through study completion, an average of 1 year.
Determination of the sensitivity of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single- lead ECG monitor CardioQvark.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
Measured: Through study completion, an average of 1 year.
Determination of specificity of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single- lead ECG monitor CardioQvark.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
Measured: Through study completion, an average of 1 year.
Determination of prognostic value of positive and negative results of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single-channel ECG monitor CardioQvark.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
Measured: Through study completion, an average of 1 year.
Determination of area under receiver operating characteristic curve of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single- lead ECG monitor CardioQvark.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
Measured: Through study completion, an average of 1 year.
Determination of correlation coefficient of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single-channel ECG monitor CardioQvark.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
Measured: Through study completion, an average of 1 year.
assessment of the accuracy of the blood pressure measurement using a single-channel ECG monitor CardioQvark.
comparison of blood pressure values obtained on the basis of a mathematical model of pulse wave parameters and measured using a cuff-based device.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (24)
significance of the parameter TpTe on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter VAT on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter QTc on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter QT / TQ on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter QRS_E on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter T_E on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter TP_E on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter BETA on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter BETA_S on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter BAD_T on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter QRS_D1_ons on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter QRS_D1_offs on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter QRS_D2 on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter QRS_Ei on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter T_Ei on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter HFQRS on the ECG in the determination of left ventricular systolic dysfunction
an ECG spectral analysis will be performed using the Fourier Transform
Measured: Through study completion, an average of 1 year.
significance of the parameter B1 on the pulse wave in the determination of left ventricular systolic dysfunction
the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark
Measured: Through study completion, an average of 1 year.
significance of the parameter B0 on the pulse wave in the determination of left ventricular systolic dysfunction
the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark
Measured: Through study completion, an average of 1 year.
significance of the parameter SEP on the pulse wave in the determination of left ventricular systolic dysfunction
the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark
Measured: Through study completion, an average of 1 year.
significance of the parameter DER3 on the pulse wave in the determination of left ventricular systolic dysfunction
the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark
Measured: Through study completion, an average of 1 year.
significance of the parameter SEPMAX on the pulse wave in the determination of left ventricular systolic dysfunction
the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark
Measured: Through study completion, an average of 1 year.
significance of the parameter SRP on the pulse wave in the determination of left ventricular systolic dysfunction
the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark
Measured: Through study completion, an average of 1 year.
significance of the parameter DP on the pulse wave in the determination of left ventricular systolic dysfunction
the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark
Measured: Through study completion, an average of 1 year.
significance of the parameter perfusion index on the pulse wave in the determination of left ventricular systolic dysfunction
the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Dec 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petr Chomakhidze, Professor, Study director, I.M. Sechenov First Moscow State Medical University (Sechenov University)Zhanna Sagirova, Graduate, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788342
- Sponsor's protocol ID
- S17022021
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research sponsor is Sechenov University. Data disclosure is not permitted by the local ethics committee. For more information about the study, you need to contact the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Wave Parameters Registered by a Single-lead Electrocardiogram Monitor With Photoplethysmography Function in the Assessment of Systolic Function of the Left Ventricle.
- ClinicalTrials.gov ID
- NCT04788342
- Acronym / sponsor ID
- S17022021
- Conditions
- Hypertension, Heart Failure
- Keywords
- pulse wave, systolic function of the left ventricle, ejection fraction, blood pressure, a single-lead electrocardiogram, remote determination of the systolic function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-center, non-randomized, observational study. The aim of this study is to determine the potential of a single-lead electrocardiogram monitor CardioQvark with photoplethysmography function use to evaluate systolic function of the left ventricle.
The study is conducted in the clinic of I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia. It is planned to include 400 patients. Recording of the electrocardiogram and photoplethysmogram by the monitor CardioQvark and the assessment of systolic function using echocardiography will be performed in all study participants.
The result of this study will be the identification of the parameters of the pulse wave and electrocardiogram that will correlate with systolic function of the left ventricle. It is also planned to determine the diagnostic effectiveness of this method.
Detailed description
The aim of this study is to determine the potential of a single-lead electrocardiogram (ECG) monitor CardioQvark (Moscow, Russia) with photoplethysmography function use to evaluate parameters systolic function of the left ventricle. Also according to the photoplethysmogram (PPG), using a special algorithm, the levels of systolic and diastolic blood pressure are calculated.
The single-lead electrocardiogram monitor CardioQvark (it is registered with the Federal Service for Health Supervision on February 15, 2019. RZN (Roszdravnadzor) No. 2019/8124) looks like an iPhone cover and records electrocardiogram (I standard lead) and photoplethysmogram (pulse wave) simultaneously.
This is a prospective, single-center, non-randomized, observational study. The investigators are planning to include in the study 400 patients with different pathologies of the cardiovascular system (coronary artery disease, hypertension, valvular heart disease, heart failure) according to the inclusion criteria.
Collection of medical history; physical examination (including inspection, palpation and auscultation, as well as determination of breathing rate, pulse rate, height, and weight) will be performed for the entire group of patients. Electrocardiogram and photoplethysmogram registration and assessment of the blood pressure using a CardioQvark monitor will be performed on all study participants at rest (the patient will sit quietly for 10-15 minutes before the examination). The reference blood pressure will be measured using a cuff-based blood pressure device ("Microlife BP AG1-10") that is worn on the upper arm according to the World Health Organization recommendations.
All subjects will undergo an echocardiography ("Dimension/Vivid 7 PRO General Electric Medical System"), the examination will be performed by an experienced doctor (the doctor will not have data on the parameters of the pulse wave and electrocardiogram). The extended protocol echocardiography will be performed according to the recommendations of European Association of Cardiovascular Imaging (EACVI) and American Society of Echocardiography (ASE). All examinations will be performed consistently within one day.
All electrocardiograms and photoplethysmograms records will be sent to the CardioQVARK server and processed by the algorithm using signal processing based on the wavelet transformation. Then engineers of "CardioQvark" (Limited Liability Company) will calculate the pulse wave parameters:
- B1 is the beginning of the wave
- B0 is the point of maximum increase of the anterior front
- SEP is the peak of the ejected pulse wave
- DER3 is the first positive peak of the third derivative
- SEPMAX is the point of the first inflection of pulse wave
- SRP is the peak of the reflected systolic wave
- DP is the peak of the diastolic wave
- End is the end of the wave
- perfusion index
- augmentation index.
A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform, the principles of which are based on the Fourier transform:
- TpTe - time from peak to end of the T-wave
- VAT - time from the beginning of the QRS to the R-peak
- QTc - corrected QT interval.
- QT / TQ - the ratio of QT length to TQ length (from the end of T to the beginning of the QRS of the next complex).
- QRS_E - the total energy of the QRS wave based on the wavelet transform
- T_E - T-wave total energy based on wavelet transform
- TP_E- energy of the main tooth of the T-wave based on the wavelet transform
- BETA, BETA_S - T-wave asymmetry coefficients (simple and smooth versions)
- BAD_T - flag of T-wave quality (whether expressed in the current lead
- QRS_D1_ons - energy of the leading edge of the R-wave (based on the "first derivative" wavelet transform)
- QRS_D1_offs - energy of the trailing edge of the R-wave (based on the "first derivative" wavelet transform)
- QRS_D2 - peak energy of the R-wave (based on the "second derivative" wavelet transform)
- QRS_Ei (i = 1,2,3,4) - QRS-wave energy in 4 frequency ranges (2-4-8-16-32 Hz) based on wavelet transform
- T_Ei (i = 1,2,3,4) - T-wave energy in 4 frequency ranges (2-4-6-8-10 Hz) based on wavelet transform
- HFQRS - the amplitude of the RF components of the QRS wave. The engineers will not have echocardiography results.
The investigators will evaluate parameters of the pulse wave (photoplethysmogram) and electrocardiogram and compare the results with echocardiography (ejection fraction, left ventricular outflow tract velocity time integral (VTI), left ventricular global longitudinal strain (GLS)).The mathematical model for determining the systolic dysfunction of the left ventricle will be built on the basis of the parameters of the photoplethysmogram and the electrocardiogram.
Intergroup analysis of significant differences, correlation analysis and Bland-Altman method will be used for statistical data analysis. All statistical analyses will be perform using a computer program for statistical processing of data SPPS (statistical package for the social sciences) Statistics Version 26.
It is planned to obtain comparative characteristics of the pulse wave and electrocardiogram parameters registered by the CardioQvark monitor and the indicators of systolic function of the left ventricle detected during echocardiography. The result of this study will be the identification of the parameters of the pulse wave and electrocardiogram that will correlate with systolic dysfunction of the left ventricle. It is planned to determine the diagnostic effectiveness of this method. The accuracy of the blood pressure measurement using the CardioQvark monitor will also be evaluated.
Thus, a quick and convenient assessment of systolic function of the left ventricle and blood pressure measurement will be available. So, study results will improve the diagnosis and treatment of cardiovascular disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with and without left ventricular systolic dysfunction | – | Device: pulse wave recording, echocardiography.Patients with different pathologies of the cardiovascular system (coronary artery disease, hypertension, valvular heart disease, heart failure) will be performed pulse wave recording using a CardioQvark cardiomonitor and echocardiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with different pathologies of the cardiovascular system (coronary artery disease, hypertension, valvular heart disease, heart failure) aged 18 years and older.
Key inclusion criteria (3 listed)
- The presence of written informed consent of the patient to participate in the study.
- The presence of diagnosed cardiac pathology according anamnesis (coronary artery disease (I-IV classes according Canadian Cardiovascular Society grading of angina pectoris, post myocardial infarction, patients after percutaneous coronary intervention or coronary artery bypass grafting); hypertension (stages I- III); valvular heart disease (except patients with aortic valve stenosis and mechanical prosthetic heart valve); heart failure (I-IV NYHA).
- -
Key exclusion criteria (9 listed)
- 1. Patient's reluctance to participate in the study. 2. Poor quality of ECG recording by a single-channel ECG monitor. 3. Poor visualization of the heart during echocardiography.
- -
- The presence of rhythm and conduction disorders (WPW syndrome, frequent premature ventricular complexes, 2nd and 3rd degree sinoatrial block, 3rd degree atrioventricular block, complete left bundle branch block, complete right bundle branch block).
- Patients with permanent cardiac pacemaker, cardio-resynchronization therapy (CRT), implantable cardioverter-defibrillator (ICD).
- Conditions that can impair ECG recording quality (Parkinson's disease, essential tremor, etc.) or conditions that make it difficult to record ECG and photoplethysmogram (traumatic arm amputation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulse wave recording, echocardiography.Also: blood pressure measurementpulse wave recording using a single-channel electrocardiogram cardiomonitor with photoplethysmography, conducting echocardiography according to a standard protocol with the determination of systolic function of the left ventricle | Device | Patients with and without left ventricular systolic dysfunction |
Primary outcome
Determination of the comparative characteristics of the pulse wave parameters registered by a single- lead ECG monitor CardioQvark and indicators of systolic function of the left ventricle detected during echocardiography.
Time frame: Through study completion, an average of 1 year.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
Diagnostic accuracy of the pulse wave and electrocardiogram parameters registered by a single- lead ECG monitor CardioQvark.
Time frame: Through study completion, an average of 1 year.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
Determination of the sensitivity of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single- lead ECG monitor CardioQvark.
Time frame: Through study completion, an average of 1 year.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
Determination of specificity of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single- lead ECG monitor CardioQvark.
Time frame: Through study completion, an average of 1 year.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
Determination of prognostic value of positive and negative results of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single-channel ECG monitor CardioQvark.
Time frame: Through study completion, an average of 1 year.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
Determination of area under receiver operating characteristic curve of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single- lead ECG monitor CardioQvark.
Time frame: Through study completion, an average of 1 year.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
Determination of correlation coefficient of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single-channel ECG monitor CardioQvark.
Time frame: Through study completion, an average of 1 year.
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.
assessment of the accuracy of the blood pressure measurement using a single-channel ECG monitor CardioQvark.
Time frame: Through study completion, an average of 1 year.
comparison of blood pressure values obtained on the basis of a mathematical model of pulse wave parameters and measured using a cuff-based device.
24 secondary outcomes
significance of the parameter TpTe on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter VAT on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter QTc on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter QT / TQ on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter QRS_E on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter T_E on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter TP_E on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter BETA on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter BETA_S on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter BAD_T on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter QRS_D1_ons on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter QRS_D1_offs on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter QRS_D2 on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter QRS_Ei on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter T_Ei on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter HFQRS on the ECG in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter B1 on the pulse wave in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter B0 on the pulse wave in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter SEP on the pulse wave in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter DER3 on the pulse wave in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter SEPMAX on the pulse wave in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter SRP on the pulse wave in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter DP on the pulse wave in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
significance of the parameter perfusion index on the pulse wave in the determination of left ventricular systolic dysfunction
Time frame: Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: No. The research sponsor is Sechenov University. Data disclosure is not permitted by the local ethics committee. For more information about the study, you need to contact the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Chomakhidze, Professor study director
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Zhanna Sagirova, Graduate principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Heart Failure, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the comparative characteristics of the pulse wave parameters registered by a single- lead ECG monitor CardioQvark and indicators of systolic function of the left ventricle detected during echocardiography. (time frame: Through study completion, an average of 1 year.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.