COVID-19NCT05608603
Diagnostics of Coronavirus Disease 2019 Cardiovascular Complications
An observational study of COVID-19 and Endothelial Function, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Aim of this prospective, observational, multi-centered, randomized study is to detect cardiovascular complications in patients after coronavirus infection. The study will include 100 patients who underwent confirmed by laboratory tests COVID-19 infection (polymerase chain reaction (PCR) testing, enzyme-linked… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19, Endothelial Function, Diastolic Dysfunction
- What is being tested?
- Portable cardiac monitor "CardioQvark", Cardiorespiratory stress test and Analysis of exhaled air using the Compact PTR-MS proton mass spectrometer
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 2 Jun 2022to 30 Nov 2025
- How long will I take part?
- 9 Months
- 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 80 years
- All sexes
- Adult, Older adult
Study population: The study population consist all men and women from 18 to 80 age in a community according inclusion, non-inclusion, exclusion criteria
Who may be able to join
- Written informed consent to participate in the study;
- Age 18 and over;
- Male and female;
- COVID-19 infection confirmed by laboratory tests (polymerase chain reaction testing, enzyme-linked immunosorbent assay (positive result at least 1 time) with a CT degree more that 25% of lung lesion.
- No more than 3 months after discharge from infectious department
- Non-inclusion criteria:
Show all 13Show fewer
- Unable to sign informed consent;
- Mental illness (severe dementia, schizophrenia, severe depression, manic-depressive psychosis);
- Acute coronary syndrome, acute cerebrovascular accident, pulmonary embolism within the last 3 months;
- Oncology;
- Diseases and conditions that can change the ECG picture and complicate the analysis of the ECG (conduction disturbance, pacemaker);
- Inability to use a heart monitor (congenital developmental anomalies, traumatic amputation of the upper limbs, essential tremor, Parkinson's disease);
- Severe comorbidities with life expectancy less than 1 year.
Who cannot join
- Refusal to further participation in the study;
- Acute infectious diseases, tuberculosis
- Oncology arising in the process of the study
- Acute coronary syndrome, acute cerebrovascular accident, pulmonary embolism arising in the process of the study
- Acute psychotic reactions arising in the process of the study;
- Inability to use a heart monitor arising in the process of the study
Trial locations and contacts
1 site in 1 country.
Russia1 site
I.M. Sechenov First Moscow State Medical University (Sechenov University)ogy, Center "Digital biodesign and personalized healthcare")
Moscow, 119991
About this study
Official title: Observational Cohort Prospective Study of Diagnostics of Coronavirus Disease 2019 Cardiovascular Complications Using Remote Electrocardiogram Monitoring and Pulse Wave
Aim of this prospective, observational, multi-centered, randomized study is to detect cardiovascular complications in patients after coronavirus infection.
The study will include 100 patients who underwent confirmed by laboratory tests COVID-19 infection (polymerase chain reaction (PCR) testing, enzyme-linked immunosorbent assay (positive result at least 1 time)) 1-3 months ago with the degree of lung lesion more than 25%, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University.
Read more
The study consists of 4 periods:
- Screening for up to 6 months.
- Inclusion in the study, undergoing of identical laboratory and instrumental testing.
- Re-examination of patients. After 6 months from the initial examination (9 months after discharge from the infectious diseases department), patients will be re-examined.
4 Determination of end points, statistical data processing.
Estimated result of the study is to confirm or refute the hypothesis:
- As a result of the analysis of ECG and pulse wave data and comparison with echocardiography data, identify cardiovascular complications of COVID-19 infection.
- To determine the diagnostic significance of pulse wave parameters for assessing cardiovascular complications in patients with a history of COVID-19 infection (sensitivity, specificity, positive and negative predictive value).
- Identify correlations between pulse wave parameters and biochemical markers of endothelial dysfunction (endothelin-1).
- As a result of the analysis of exhaled air by the proton mass spectrometry, to identify markers of cardiovascular complications in patients after COVID-19 infection.
- As a result of a cardiorespiratory stress test, determine the respiratory and cardiovascular causes of dyspnea, exercise tolerance of patients after infection with COVID-19.
Read the detailed description
Aim of this prospective, observational, multi-centered, randomized study is to detect cardiovascular complications in patients after coronavirus infection.
The study will include 100 patients who underwent confirmed by laboratory tests Coronavirus Disease 2019 (COVID-19) infection (polymerase chain reaction (PCR) testing, enzyme-linked immunosorbent assay (positive result at least 1 time)) 1-3 months ago with the degree of lung lesion more than 25%, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University.
The study consists of 4 periods:
- Screening for up to 6 months. Performed by a pulmonologist. Patients meeting the inclusion criteria are selected.
- Inclusion in the study. If the patient meets the inclusion criteria, a discussion about the nature of the study is held with the patient. Further, consent to participate in the study and to process personal data is obtained. After, the epicrisis from the COVID-19 infectious diseases department is analyzed. Patients are provided with medical care in accordance with the standards approved by the Ministry of Health of the Russian Federation, and local acts of the institution in which the study is carried out. Patients eligible for inclusion will undergo the following investigations:
- Anamnesis and complaints collection; physical examination;
- Assessment of the quality of life and psycho-emotional status using the Short Form-36 (SF36) and Hospital Anxiety and Depression Scale (HADS) questionnaires, as well as the six-minute walk test;
- General and biochemical blood tests , urine analysis, , determination of biochemical markers of endothelial dysfunction (endothelin-1) in the blood;
- Electrocardiography, a flow mediated dilatation procedure for endothelial function assessment, transthoracic echocardiography to identify the structural and functional features of the myocardium, spiroergometry to determine the patient's oxygen consumption.
- Electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"
- The analysis of exhaled air will be performed using the Compact proton mass spectrometer (PTR-MS) manufactured by Ionicon (Austria).
- Re-examination of patients. After 6 months from the initial examination (9 months after discharge from the infectious diseases department), patients will be re-examined, In the interval between the initial and repeated examinations, the condition of all patients will be monitored, for this it is expected to make phone calls, the frequency of 1 time per month.
4 Determination of end points, statistical data processing. The statistical processing will be performed using the Python Software Foundation version 3.8 for Windows (Delaware, USA).
Estimated result of the study is to confirm or refute the hypothesis:
- As a result of the analysis of ECG and pulse wave data and comparison with echocardiography data, identify cardiovascular complications of COVID-19 infection.
- To determine the diagnostic significance of pulse wave parameters for assessing cardiovascular complications in patients with a history of COVID-19 infection (sensitivity, specificity, positive and negative predictive value).
- Identify correlations between pulse wave parameters and biochemical markers of endothelial dysfunction (endothelin-1).
- As a result of the analysis of exhaled air by the proton mass spectrometry, to identify markers of cardiovascular complications in patients after COVID-19 infection.
- As a result of a cardiorespiratory stress test, determine the respiratory and cardiovascular causes of dyspnea, exercise tolerance of patients after infection with COVID-19.
- Conditions
- COVID-19, Endothelial Function, Diastolic Dysfunction, Oxygen Consumption, Quality of Life, Exercise Tolerance
- Being tested
- Portable cardiac monitor "CardioQvark", Cardiorespiratory stress test, Analysis of exhaled air using the Compact PTR-MS proton mass spectrometer
- Keywords
- COVID-19, markers of endothelial function, diastolic dysfunction, oxygen consumption, flow mediated dilatation, proton mass spectrometry, remote ECG monitoring, pulse vawe
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable cardiac monitor "CardioQvark"Diagnostic test
Also called Electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"
Record an electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark" (Russia, LLC "L Card" , RU No. RZN 2019/8124 dated February 15, 2019) once. Devices automatically transfer data to the A\&D Connect app paired with it (link). When transferring data, they are completely protected. The data obtained using the application must be sent to the specialists of the research group in a depersonalized form.
Cardiorespiratory stress testDiagnostic test
Cardiorespiratory stress testing with gas analysis using the Quark CPET diagnostic system (COSMED, Italy). The study protocol will consist of 4 phases: rest, warm-up, exercise and recovery. During the load phase, a ramp protocol will be used with a stepped load from 10 to 25 W/min. The increase in power will be calculated individually before the start of the study so that the test lasts 8-12 minutes until complete muscle failure.
Analysis of exhaled air using the Compact PTR-MS proton mass spectrometerDiagnostic test
The analysis of exhaled air will be performed using the Compact PTR-MS proton mass spectrometer manufactured by Ionicon (Austria)
| Study group | Role | What they receive |
|---|---|---|
| 3 months postcovid patients | Included 100 patients, aged 18-80 years old, at 3 months after infection COVID-19.
Intervention: cardiorespiratory stress test to determine the patient's oxygen consumption; electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"; the analysis of exhaled air will be performed using the Compact PTR-MS proton mass spectrometer manufactured by Ionicon (Austria). Receives: Diagnostic Test: Portable cardiac monitor "CardioQvark"; Diagnostic Test: Cardiorespiratory stress test; Diagnostic Test: Analysis of exhaled air using the Compact PTR-MS proton mass spectrometer | |
| 9 months postcovid patients | Included the same 100 patients, aged 18-80 years old, at 9 months after infection COVID-19.
Intervention: cardiorespiratory stress test to determine the patient's oxygen consumption; electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"; the analysis of exhaled air will be performed using the Compact PTR-MS proton mass spectrometer manufactured by Ionicon (Austria). Receives: Diagnostic Test: Portable cardiac monitor "CardioQvark"; Diagnostic Test: Cardiorespiratory stress test; Diagnostic Test: Analysis of exhaled air using the Compact PTR-MS proton mass spectrometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in endothelin-1 in dynamics (compared with initial indicators)
This outcome will be assessed by taking blood samples from a peripheral vein
Measured: In 9 months after the recovery from COVID-19
Changes in the diastolic function of the right and left ventricles (compared with initial indicators)
Transthoracic echocardiography (EchoCG) will be performed to assess the heart structure and function: unidimensional (M-mode), two-dimensional (B-mode) and Doppler.
Diastolic function of the left ventricle will be assessed using pulse-wave, constant-wave, and tissue Doppler studies. Maximum velocity of early (E peak) and late (A peak) diastolic filling, E/A ratio, time of blood flow deceleration of early left ventricular diastolic filling (DT) will be determined at simultaneous recording of aortic and transmitral blood flow in constant-wave mode, left ventricular isovolumic relaxation time (IVRT) - interval from the end of aortic to the beginning of transmitral blood flow.
Measured: In 9 months after the recovery from COVID-19
Change in ejection fraction (compared with initial indicators)
Transthoracic EchoCG will be performed to assess the heart structure and function: unidimensional (M-mode), two-dimensional (B-mode) and Doppler.
Ejection fraction will be assessed according to BIPLANE, TAPSE.
Measured: In 9 months after the recovery from COVID-19
Changes in the volumes of the heart cavities (compared with initial indicators)
Transthoracic EchoCG will be performed to assess the heart structure and function: unidimensional (M-mode), two-dimensional (B-mode) and Doppler.
Measured: In 9 months after the recovery from COVID-19
Change in speed indicators on the heart valves (compared with initial indicators)
Transthoracic EchoCG will be performed to assess the heart structure and function: unidimensional (M-mode), two-dimensional (B-mode) and Doppler.
Measured: In 9 months after the recovery from COVID-19
Change in mean and diastolic pressure of the pulmonary artery (compared with initial indicators)
Transthoracic EchoCG will be performed to assess the heart structure and function: unidimensional (M-mode), two-dimensional (B-mode) and Doppler.
Measured: In 9 months after the recovery from COVID-19
Changes in the cardio-ankle vascular index and ankle-brachial index (compared with initial indicators)
Will be assessed by using pulse wave measurements in dynamics
Measured: In 9 months after the recovery from COVID-19
Changes in the spectrum of volatile organic compounds in exhaled air in patients after COVID-19 infection over time (compared with initial indicators)
Will be assessed by using exhale air proton mass spectrometry in dynamics.
Measured: In 9 months after the recovery from COVID-19
Change in oxygen pulse (VO2/HR) at the peak of the load
The spiroergometric test will be performed under continuous stepwise increasing load. The duration of each load step is 5 min; the initial load level is 25 W, followed by an increase in load at each step by the same amount. The results of the test will be used to evaluate the achievement of the maximum level of oxygen consumption (in l/min or ml/min/kg body weight) and the maximum achievement of the "oxygen pulse" on load.
Measured: In 9 months after the recovery from COVID-19
Changes in ventilation parameters (tidal volume (Vt), minute ventilation (VE), Vt/FVC index (ratio of tidal volume to forced vital capacity), respiratory reserve (BR)) over time
The spiroergometric test will be performed under continuous stepwise increasing load. The duration of each load step is 5 min; the initial load level is 25 W, followed by an increase in load at each step by the same amount. The results of the test will be used to evaluate the achievement of the maximum level of oxygen consumption (in l/min or ml/min/kg body weight) and the maximum achievement of the "oxygen pulse" on load.
Measured: In 9 months after the recovery from COVID-19
Changes in gas exchange parameters (end-expiratory partial pressure of exhaled carbon dioxide (PetCO2), ventilation equivalent for carbon dioxide (VE/VCO2), ventilation-perfusion ratio (Vd/Vt)) in dynamics
The spiroergometric test will be performed under continuous stepwise increasing load. The duration of each load step is 5 min; the initial load level is 25 W, followed by an increase in load at each step by the same amount. The results of the test will be used to evaluate the achievement of the maximum level of oxygen consumption (in l/min or ml/min/kg body weight) and the maximum achievement of the "oxygen pulse" on load.
Measured: In 9 months after the recovery from COVID-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start2 Jun 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 100 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Yu Kopylov, Professor, Study director, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608603
- Sponsor's protocol ID
- 12211
- Status last verified
- Mar 2024
- First submitted
- 5 Nov 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Prohibition of local ethics committee
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Prospective Study of Diagnostics of Coronavirus Disease 2019 Cardiovascular Complications Using Remote Electrocardiogram Monitoring and Pulse Wave
- ClinicalTrials.gov ID
- NCT05608603
- Acronym / sponsor ID
- 12211
- Conditions
- COVID-19, Endothelial Function, Diastolic Dysfunction, Oxygen Consumption, Quality of Life, Exercise Tolerance
- Keywords
- COVID-19, markers of endothelial function, diastolic dysfunction, oxygen consumption, flow mediated dilatation, proton mass spectrometry, remote ECG monitoring, pulse vawe
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 8 Nov 2022 (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.
Aim of this prospective, observational, multi-centered, randomized study is to detect cardiovascular complications in patients after coronavirus infection.
The study will include 100 patients who underwent confirmed by laboratory tests COVID-19 infection (polymerase chain reaction (PCR) testing, enzyme-linked immunosorbent assay (positive result at least 1 time)) 1-3 months ago with the degree of lung lesion more than 25%, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University.
The study consists of 4 periods:
- Screening for up to 6 months.
- Inclusion in the study, undergoing of identical laboratory and instrumental testing.
- Re-examination of patients. After 6 months from the initial examination (9 months after discharge from the infectious diseases department), patients will be re-examined.
4 Determination of end points, statistical data processing.
Estimated result of the study is to confirm or refute the hypothesis:
- As a result of the analysis of ECG and pulse wave data and comparison with echocardiography data, identify cardiovascular complications of COVID-19 infection.
- To determine the diagnostic significance of pulse wave parameters for assessing cardiovascular complications in patients with a history of COVID-19 infection (sensitivity, specificity, positive and negative predictive value).
- Identify correlations between pulse wave parameters and biochemical markers of endothelial dysfunction (endothelin-1).
- As a result of the analysis of exhaled air by the proton mass spectrometry, to identify markers of cardiovascular complications in patients after COVID-19 infection.
- As a result of a cardiorespiratory stress test, determine the respiratory and cardiovascular causes of dyspnea, exercise tolerance of patients after infection with COVID-19.
Detailed description
Aim of this prospective, observational, multi-centered, randomized study is to detect cardiovascular complications in patients after coronavirus infection.
The study will include 100 patients who underwent confirmed by laboratory tests Coronavirus Disease 2019 (COVID-19) infection (polymerase chain reaction (PCR) testing, enzyme-linked immunosorbent assay (positive result at least 1 time)) 1-3 months ago with the degree of lung lesion more than 25%, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University.
The study consists of 4 periods:
- Screening for up to 6 months. Performed by a pulmonologist. Patients meeting the inclusion criteria are selected.
- Inclusion in the study. If the patient meets the inclusion criteria, a discussion about the nature of the study is held with the patient. Further, consent to participate in the study and to process personal data is obtained. After, the epicrisis from the COVID-19 infectious diseases department is analyzed. Patients are provided with medical care in accordance with the standards approved by the Ministry of Health of the Russian Federation, and local acts of the institution in which the study is carried out. Patients eligible for inclusion will undergo the following investigations:
- Anamnesis and complaints collection; physical examination;
- Assessment of the quality of life and psycho-emotional status using the Short Form-36 (SF36) and Hospital Anxiety and Depression Scale (HADS) questionnaires, as well as the six-minute walk test;
- General and biochemical blood tests , urine analysis, , determination of biochemical markers of endothelial dysfunction (endothelin-1) in the blood;
- Electrocardiography, a flow mediated dilatation procedure for endothelial function assessment, transthoracic echocardiography to identify the structural and functional features of the myocardium, spiroergometry to determine the patient's oxygen consumption.
- Electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"
- The analysis of exhaled air will be performed using the Compact proton mass spectrometer (PTR-MS) manufactured by Ionicon (Austria).
- Re-examination of patients. After 6 months from the initial examination (9 months after discharge from the infectious diseases department), patients will be re-examined, In the interval between the initial and repeated examinations, the condition of all patients will be monitored, for this it is expected to make phone calls, the frequency of 1 time per month.
4 Determination of end points, statistical data processing. The statistical processing will be performed using the Python Software Foundation version 3.8 for Windows (Delaware, USA).
Estimated result of the study is to confirm or refute the hypothesis:
- As a result of the analysis of ECG and pulse wave data and comparison with echocardiography data, identify cardiovascular complications of COVID-19 infection.
- To determine the diagnostic significance of pulse wave parameters for assessing cardiovascular complications in patients with a history of COVID-19 infection (sensitivity, specificity, positive and negative predictive value).
- Identify correlations between pulse wave parameters and biochemical markers of endothelial dysfunction (endothelin-1).
- As a result of the analysis of exhaled air by the proton mass spectrometry, to identify markers of cardiovascular complications in patients after COVID-19 infection.
- As a result of a cardiorespiratory stress test, determine the respiratory and cardiovascular causes of dyspnea, exercise tolerance of patients after infection with COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 months postcovid patients | – | Diagnostic Test: Portable cardiac monitor "CardioQvark", Diagnostic Test: Cardiorespiratory stress test, Diagnostic Test: Analysis of exhaled air using the Compact PTR-MS proton mass spectrometerIncluded 100 patients, aged 18-80 years old, at 3 months after infection COVID-19. Intervention: cardiorespiratory stress test to determine the patient's oxygen consumption; electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"; the analysis of exhaled air will be performed using the Compact PTR-MS proton mass spectrometer manufactured by Ionicon (Austria). |
| 9 months postcovid patients | – | Diagnostic Test: Portable cardiac monitor "CardioQvark", Diagnostic Test: Cardiorespiratory stress test, Diagnostic Test: Analysis of exhaled air using the Compact PTR-MS proton mass spectrometerIncluded the same 100 patients, aged 18-80 years old, at 9 months after infection COVID-19. Intervention: cardiorespiratory stress test to determine the patient's oxygen consumption; electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"; the analysis of exhaled air will be performed using the Compact PTR-MS proton mass spectrometer manufactured by Ionicon (Austria). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consist all men and women from 18 to 80 age in a community according inclusion, non-inclusion, exclusion criteria
Key inclusion criteria (13 listed)
- Written informed consent to participate in the study;
- Age 18 and over;
- Male and female;
- COVID-19 infection confirmed by laboratory tests (polymerase chain reaction testing, enzyme-linked immunosorbent assay (positive result at least 1 time) with a CT degree more that 25% of lung lesion.
- No more than 3 months after discharge from infectious department
Key exclusion criteria (6 listed)
- Refusal to further participation in the study;
- Acute infectious diseases, tuberculosis
- Oncology arising in the process of the study
- Acute coronary syndrome, acute cerebrovascular accident, pulmonary embolism arising in the process of the study
- Acute psychotic reactions arising in the process of 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 |
|---|---|---|
| Portable cardiac monitor "CardioQvark"Also: Electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"Record an electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark" (Russia, LLC "L Card" , RU No. RZN 2019/8124 dated February 15, 2019) once. Devices automatically transfer data to the A\&D Connect app paired with it (link). When transferring data, they are completely protected. The data obtained using the application must be sent to the specialists of the research group in a depersonalized form. | Diagnostic test | 3 months postcovid patients, 9 months postcovid patients |
| Cardiorespiratory stress testCardiorespiratory stress testing with gas analysis using the Quark CPET diagnostic system (COSMED, Italy). The study protocol will consist of 4 phases: rest, warm-up, exercise and recovery. During the load phase, a ramp protocol will be used with a stepped load from 10 to 25 W/min. The increase in power will be calculated individually before the start of the study so that the test lasts 8-12 minutes until complete muscle failure. | Diagnostic test | 3 months postcovid patients, 9 months postcovid patients |
| Analysis of exhaled air using the Compact PTR-MS proton mass spectrometerThe analysis of exhaled air will be performed using the Compact PTR-MS proton mass spectrometer manufactured by Ionicon (Austria) | Diagnostic test | 3 months postcovid patients, 9 months postcovid patients |
Primary outcome
Changes in endothelin-1 in dynamics (compared with initial indicators)
Time frame: In 9 months after the recovery from COVID-19
This outcome will be assessed by taking blood samples from a peripheral vein
Changes in the diastolic function of the right and left ventricles (compared with initial indicators)
Time frame: In 9 months after the recovery from COVID-19
Transthoracic echocardiography (EchoCG) will be performed to assess the heart structure and function: unidimensional (M-mode), two-dimensional (B-mode) and Doppler. Diastolic function of the left ventricle will be assessed using pulse-wave, constant-wave, and tissue Doppler studies. Maximum velocity of early (E peak) and late (A peak) diastolic filling, E/A ratio, time of blood flow deceleration of early left ventricular diastolic filling (DT) will be determined at simultaneous recording of aortic and transmitral blood flow in constant-wave mode, left ventricular isovolumic relaxation time (IVRT) - interval from the end of aortic to the beginning of transmitral blood flow.
Change in ejection fraction (compared with initial indicators)
Time frame: In 9 months after the recovery from COVID-19
Transthoracic EchoCG will be performed to assess the heart structure and function: unidimensional (M-mode), two-dimensional (B-mode) and Doppler. Ejection fraction will be assessed according to BIPLANE, TAPSE.
Changes in the volumes of the heart cavities (compared with initial indicators)
Time frame: In 9 months after the recovery from COVID-19
Transthoracic EchoCG will be performed to assess the heart structure and function: unidimensional (M-mode), two-dimensional (B-mode) and Doppler.
Change in speed indicators on the heart valves (compared with initial indicators)
Time frame: In 9 months after the recovery from COVID-19
Transthoracic EchoCG will be performed to assess the heart structure and function: unidimensional (M-mode), two-dimensional (B-mode) and Doppler.
Change in mean and diastolic pressure of the pulmonary artery (compared with initial indicators)
Time frame: In 9 months after the recovery from COVID-19
Transthoracic EchoCG will be performed to assess the heart structure and function: unidimensional (M-mode), two-dimensional (B-mode) and Doppler.
Changes in the cardio-ankle vascular index and ankle-brachial index (compared with initial indicators)
Time frame: In 9 months after the recovery from COVID-19
Will be assessed by using pulse wave measurements in dynamics
Changes in the spectrum of volatile organic compounds in exhaled air in patients after COVID-19 infection over time (compared with initial indicators)
Time frame: In 9 months after the recovery from COVID-19
Will be assessed by using exhale air proton mass spectrometry in dynamics.
Change in oxygen pulse (VO2/HR) at the peak of the load
Time frame: In 9 months after the recovery from COVID-19
The spiroergometric test will be performed under continuous stepwise increasing load. The duration of each load step is 5 min; the initial load level is 25 W, followed by an increase in load at each step by the same amount. The results of the test will be used to evaluate the achievement of the maximum level of oxygen consumption (in l/min or ml/min/kg body weight) and the maximum achievement of the "oxygen pulse" on load.
Changes in ventilation parameters (tidal volume (Vt), minute ventilation (VE), Vt/FVC index (ratio of tidal volume to forced vital capacity), respiratory reserve (BR)) over time
Time frame: In 9 months after the recovery from COVID-19
The spiroergometric test will be performed under continuous stepwise increasing load. The duration of each load step is 5 min; the initial load level is 25 W, followed by an increase in load at each step by the same amount. The results of the test will be used to evaluate the achievement of the maximum level of oxygen consumption (in l/min or ml/min/kg body weight) and the maximum achievement of the "oxygen pulse" on load.
Changes in gas exchange parameters (end-expiratory partial pressure of exhaled carbon dioxide (PetCO2), ventilation equivalent for carbon dioxide (VE/VCO2), ventilation-perfusion ratio (Vd/Vt)) in dynamics
Time frame: In 9 months after the recovery from COVID-19
The spiroergometric test will be performed under continuous stepwise increasing load. The duration of each load step is 5 min; the initial load level is 25 W, followed by an increase in load at each step by the same amount. The results of the test will be used to evaluate the achievement of the maximum level of oxygen consumption (in l/min or ml/min/kg body weight) and the maximum achievement of the "oxygen pulse" on load.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No. Prohibition of local ethics committee
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COVID -19
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.
Philippe Yu Kopylov, Professor study director
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 COVID-19 and Endothelial 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 13 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. 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?
Results are not available in the source record.
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?
Changes in endothelin-1 in dynamics (compared with initial indicators) (time frame: In 9 months after the recovery from COVID-19). The study lists 11 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 20 Mar 2024.