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Recruiting NCT05608603

Diagnostics of COVID-19 Cardiovascular Complications

Conditions: COVID-19, Endothelial Function, Diastolic Dysfunction, Oxygen Consumption, Quality of Life, Exercise Tolerance

Sex: All
Ages: 18 Years – 80 Years
Enrollment: 100
Sponsor: I.M. Sechenov First Moscow State Medical University

Location: Russian Federation

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: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.

Eligibility Criteria

Inclusion Criteria: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 lession.No more than 3 months after discharge from infectious departmentNon-inclusion criteria: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.Exclusion Criteria:Refusal to further participation in the study;Acute infectious diseases, tuberculosisOncology arising in the process of the studyAcute coronary syndrome, acute cerebrovascular accident, pulmonary embolism arising in the process of the studyAcute psychotic reactions arising in the process of the study;Inability to use a heart monitor arising in the process of the study

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05608603). StuddyBuddy aggregates publicly available trial information.