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Diagnostics of COVID-19 Cardiovascular Complications
ClinicalTrials.gov; 05/11/2022; TrialID: NCT05608603
Clinical Trial Register | ICTRP | ID: ictrp-NCT05608603
ABSTRACT

Condition

COVID-19;Endothelial Function;Diastolic Dysfunction;Oxygen Consumption;Quality of Life;Exercise Tolerance

Intervention

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

Primary 

outcome:

Changes in endothelin-1 in dynamics (compared with initial indicators);Changes in the diastolic function of the right and left ventricles (compared with initial indicators);Change in ejection fraction (compared with initial indicators);Changes in the volumes of the heart cavities (compared with initial indicators);Change in speed indicators on the heart valves (compared with initial indicators);Change in mean and diastolic pressure of the pulmonary artery (compared with initial indicators);Changes in the cardio-ankle vascular index and ankle-brachial index (compared with initial indicators);Changes in the spectrum of volatile organic compounds in exhaled air in patients after COVID-19 infection over time (compared with initial indicators);Change in oxygen pulse (VO2/HR) at the peak of the 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;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

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 lession.

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

Non-inclusion criteria

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


Collection: Clinical trial registers Database: ICTRP Year: 2022 Document Type: Clinical Trial Register

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Collection: Clinical trial registers Database: ICTRP Year: 2022 Document Type: Clinical Trial Register