Diagnostics of Coronavirus Disease 2019 Cardiovascular Complications

NCT ID: NCT05608603

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-02
• Study Completion Date: 2025-11-30

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. Screening for up to 6 months.

2. Inclusion in the study, undergoing of identical laboratory and instrumental testing.

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 Determination of end points, statistical data processing.

Estimated result of the study is to confirm or refute the hypothesis:

1. As a result of the analysis of ECG and pulse wave data and comparison with echocardiography data, identify cardiovascular complications of COVID-19 infection.

2. 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).

3. Identify correlations between pulse wave parameters and biochemical markers of endothelial dysfunction (endothelin-1).

4. 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.

5. 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:

1. Screening for up to 6 months. Performed by a pulmonologist. Patients meeting the inclusion criteria are selected.

2. 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).

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, 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:

1. As a result of the analysis of ECG and pulse wave data and comparison with echocardiography data, identify cardiovascular complications of COVID-19 infection.

2. 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).

3. Identify correlations between pulse wave parameters and biochemical markers of endothelial dysfunction (endothelin-1).

4. 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.

5. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Portable cardiac monitor "CardioQvark"

Intervention Type: 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.

Cardiorespiratory stress test

Intervention Type: 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.

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

Intervention Type: DIAGNOSTIC_TEST

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

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).

Portable cardiac monitor "CardioQvark"

Intervention Type: 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.

Cardiorespiratory stress test

Intervention Type: 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.

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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Cardiorespiratory stress 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.

Intervention Type: DIAGNOSTIC_TEST

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

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

1. Written informed consent to participate in the study;

2. Age 18 and over;

3. Male and female;

4. 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.

5. No more than 3 months after discharge from infectious department

1. Unable to sign informed consent;

2. Mental illness (severe dementia, schizophrenia, severe depression, manic-depressive psychosis);

3. Acute coronary syndrome, acute cerebrovascular accident, pulmonary embolism within the last 3 months;

4. Oncology;

5. Diseases and conditions that can change the ECG picture and complicate the analysis of the ECG (conduction disturbance, pacemaker);

6. Inability to use a heart monitor (congenital developmental anomalies, traumatic amputation of the upper limbs, essential tremor, Parkinson's disease);

7. Severe comorbidities with life expectancy less than 1 year.

Exclusion Criteria

1. Refusal to further participation in the study;

2. Acute infectious diseases, tuberculosis

3. Oncology arising in the process of the study

4. Acute coronary syndrome, acute cerebrovascular accident, pulmonary embolism arising in the process of the study

5. Acute psychotic reactions arising in the process of the study;

6. Inability to use a heart monitor arising in the process of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Yu Kopylov, Professor

Role: STUDY_DIRECTOR

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

Locations

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

Moscow, , Russia

Countries

Russia

Other Identifiers

12211

Identifier Type: -

Identifier Source: org_study_id