Diagnostics of Coronavirus Disease 2019 Cardiovascular Complications

NCT05608603 | Enrolling By Invitation DMC

• 1 other identifier: 12211
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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:

1. 1.Screening for up to 6 months.
2. 2.Inclusion in the study, undergoing of identical laboratory and instrumental testing.
3. 3.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. 4.As a result of the analysis of ECG and pulse wave data and comparison with echocardiography data, identify cardiovascular complications of COVID-19 infection.
5. 5.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).
6. 6.Identify correlations between pulse wave parameters and biochemical markers of endothelial dysfunction (endothelin-1).
7. 7.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.
8. 8.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

Keywords

COVID-19; markers of endothelial function; diastolic dysfunction; oxygen consumption; flow mediated dilatation; proton mass spectrometry; remote ECG monitoring; pulse vawe

Outcome Measures

Primary Outcomes (11)

• Changes in endothelin-1 in dynamics (compared with initial indicators)

  This outcome will be assessed by taking blood samples from a peripheral vein

  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.

  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.

  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.

  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.

  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.

  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

  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.

  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.

  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.

  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.

  In 9 months after the recovery from COVID-19

Study Arms (2)

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).

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).

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

Interventions

Portable cardiac monitor "CardioQvark" DIAGNOSTIC_TEST

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.

Also known as: Electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark"

3 months postcovid patients; 9 months postcovid patients

Cardiorespiratory stress test DIAGNOSTIC_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.

3 months postcovid patients; 9 months postcovid patients

Analysis of exhaled air using the Compact PTR-MS proton mass spectrometer DIAGNOSTIC_TEST

The analysis of exhaled air will be performed using the Compact PTR-MS proton mass spectrometer manufactured by Ionicon (Austria)

3 months postcovid patients; 9 months postcovid patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consist all men and women from 18 to 80 age in a community according inclusion, non-inclusion, exclusion criteria

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)ogy, Center "Digital biodesign and personalized healthcare")

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Philippe Yu Kopylov, Professor

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 8, 2022
• Study Start: June 2, 2022
• Primary Completion: December 31, 2024
• Study Completion: November 30, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)