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NCT ID: NCT05608603 Enrolling by invitation - COVID-19 Clinical Trials

Diagnostics of Coronavirus Disease 2019 Cardiovascular Complications

Start date: June 2, 2022
Phase:
Study type: Observational [Patient Registry]

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.