Diastolic FunctionNCT04474639
Determination of Diastolic Dysfunction by Single Lead Electrocardiogram
An observational study of Diastolic Function, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diastolic Function
- What is being tested?
- echocardiographic examination
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2019to 29 Aug 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all patients aged 18 to 90 years
Who may be able to join
- The presence of written informed consent of the patient to participate in the study
- Age from 18 years to 90 years
- Outpatient treatment and / or hospitalization in a research center
Who cannot join
- Reluctance of the patient to participate in the study
- Poor quality ECG recording on a single-channel ECG monitor
- Poor visualization of the heart during echocardiographic study
- Acute psychotic reactions that arose during research
- An exacerbation of chronic diseases requiring treatment tactics for the patient and preventing his further participation in the study.
- Non-inclusion criteria:
Show all 13Show fewer
- The presence of conduction disturbances in patients that impede ECG analysis (WPW syndrome, sinoatrial block of degrees 2 and 3, atrioventricular block 3 degrees, complete block of the left bundle branch block, complete block of the right bundle branch block)
- Conditions that can impair ECG recording quality (Parkinson's disease, essential tremor)
- The inability to assess diastolic function during echocardiography
- Mental illness
- Diseases with an expected life expectancy of less than 2 years
- Patients with diffuse hypokinesis of the left ventricle with a reduced ejection fraction (less than 30%)
- Patients with a pacemaker installed
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: Diastolic Dysfunction Assessment of the Left Ventricle Using Spectral Analysis of a Single Lead ECG
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.
Read more
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.
Read the detailed description
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):
- 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
Additionally used parameters:
- TpTe, VAT, QTc - are duplicated to control the correctness of the record processing (the value of the UCC should be approximately equal to the median of the tick-by-bar).
- QRSw - QRS width.
- RA, SA, TA - the amplitudes of the R, S, T-waves, respectively, are used to normalize the parameters listed above.
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:
- patients suffering from high blood pressure with patients without the above pathology
- patients with zones of a- and hypokinesis according to echocardiography as a result of a coronary circulation disorder
- patients suffering from atrial fibrillation with patients without this pathology
- men / women
- patients of different age 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.
- Conditions
- Diastolic Function
- Being tested
- echocardiographic examination
- Keywords
- diastolic function, heart failure, spectral analysis
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographic examinationDevice
conducting an echocardiographic study according to a standard protocol with the determination of diastolic dysfunction of the left ventricle
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: echocardiographic examination | |
| 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). Receives: Device: echocardiographic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 2 years
Secondary outcomes (16)
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
Measured: through study completion, an average of 2 years
significance of the parameter VAT on the ECG in the determination of LV DD
an ECG spectral analysis will be performed using the Fourier Transform
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Sep 2019
- Primary completion30 Jun 2021
- Study completion29 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic FunctionStudies 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
- Philipp Kopylov, Study director, I.M. Sechenov First Moscow State Medical University (Sechenov University)Natalia Kuznetsova, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474639
- Sponsor's protocol ID
- 1305
- Status last verified
- Aug 2021
- First submitted
- 22 Jun 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not possible to provide documentation due to the prohibition received from the local ethics committee
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diastolic Dysfunction Assessment of the Left Ventricle Using Spectral Analysis of a Single Lead ECG
- ClinicalTrials.gov ID
- NCT04474639
- Acronym / sponsor ID
- 1305
- Conditions
- Diastolic Function
- Keywords
- diastolic function, heart failure, spectral analysis
- 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 Sep 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 29 Aug 2021 (actual)
- First posted
- 17 Jul 2020 (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.
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.
Detailed description
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):
- 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
Additionally used parameters:
- TpTe, VAT, QTc - are duplicated to control the correctness of the record processing (the value of the UCC should be approximately equal to the median of the tick-by-bar).
- QRSw - QRS width.
- RA, SA, TA - the amplitudes of the R, S, T-waves, respectively, are used to normalize the parameters listed above.
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:
- patients suffering from high blood pressure with patients without the above pathology
- patients with zones of a- and hypokinesis according to echocardiography as a result of a coronary circulation disorder
- patients suffering from atrial fibrillation with patients without this pathology
- men / women
- patients of different age 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with diastolic dysfunction | – | Device: echocardiographic examinationpatients 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 | – | Device: echocardiographic examinationpatients 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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all patients aged 18 to 90 years
Key inclusion criteria (3 listed)
- The presence of written informed consent of the patient to participate in the study
- Age from 18 years to 90 years
- Outpatient treatment and / or hospitalization in a research center
Key exclusion criteria (13 listed)
- Reluctance of the patient to participate in the study
- Poor quality ECG recording on a single-channel ECG monitor
- Poor visualization of the heart during echocardiographic study
- Acute psychotic reactions that arose during research
- An exacerbation of chronic diseases requiring treatment tactics for the patient and preventing his further participation in the study.
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 |
|---|---|---|
| echocardiographic examinationconducting an echocardiographic study according to a standard protocol with the determination of diastolic dysfunction of the left ventricle | Device | with diastolic dysfunction, without diastolic dysfunction |
Primary outcome
determination of sensitivity of LV DD using a single-channel ECG monitor CardioQvark
Time frame: through study completion, an average of 2 years
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
determination of specificity of LV DD using a single-channel ECG monitor CardioQvark
Time frame: through study completion, an average of 2 years
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
determination of prognostic value of positive and negative results of LV DD using a single-channel ECG monitor CardioQvark
Time frame: through study completion, an average of 2 years
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
determination of likelihood ratio of LV DD using a single-channel ECG monitor CardioQvark
Time frame: through study completion, an average of 2 years
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
determination of area under ROC - curve of LV DD using a single-channel ECG monitor CardioQvark
Time frame: through study completion, an average of 2 years
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
determination of correlation coefficient of LV DD using a single-channel ECG monitor CardioQvark
Time frame: through study completion, an average of 2 years
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
16 secondary outcomes
significance of the parameter TpTe on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter VAT on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter QTc on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter QT / TQ on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter QRS_E on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter T_E on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter TP_E on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter BETA on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter BETA_S on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter BAD_T on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter QRS_D1_ons on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter QRS_D1_offs on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter QRS_D2 on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter QRS_Ei on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter T_Ei on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
significance of the parameter HFQRS on the ECG in the determination of LV DD
Time frame: through study completion, an average of 2 years
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 31 Aug 2021.
- Individual participant dataSharing planned: No. It is not possible to provide documentation due to the prohibition received from the local ethics committee
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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.
Philipp Kopylov study director
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Natalia Kuznetsova 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 Diastolic Function, 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 13 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 31 Aug 2021. 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 sensitivity of LV DD using a single-channel ECG monitor CardioQvark (time frame: through study completion, an average of 2 years). The study lists 6 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 31 Aug 2021.