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The primary objective of the study is to assess the cardiac status of COVID-19 pneumonia patients during 1 year after discharge
Although COVID-19 manifests in most cases with respiratory symptoms, cardiovascular abnormalities is common in hospitalized patients. Patients with cardiovascular risk factors or established disease appear to have a worse prognosis. Myocardial dysfunction could be a direct manifestation of COVID-19. The investigators hypothesize that subjects after COVID-19 pneumonia present myocardial and vascular remodeling during 1 year after discharge, even in the absence of prior cardiovascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Covid19 pneumonia patients | The study includes men and women ≥18 years old with documented COVID-19 pneumonia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of clinical, instrumental and laboratory diagnostics tests | Diagnostic Test | During follow-up visits patients undergo clinical, instrumental and laboratory diagnostics tests |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiographic assessment of cardiac function | Echocardiographic assessment of global strain parameters at 3 and 12 months after discharge | up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| МАССЕ | Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke at 3 and 12 months after discharge | up to one year |
| Quantitative analysis of parenchymal lung damage |
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Inclusion Criteria:
-Patients with documented COVID-19 pneumonia
Exclusion Criteria:
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The study includes men and women ≥18 years old with documented COVID-19 pneumonia
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| Name | Affiliation | Role |
|---|---|---|
| Elena Yaroslavskaya, PhD | Tyumen Cardiology Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science | Tyumen | 625026 | Russia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2020 | Aug 5, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Whole blood
Describe the parenchymal lung damage through a quantitative analysis with chest CT at 3 and 12 months after discharge
| up to one year |
| Functional exercises capacity assessment | Six-min walk test at 3 and 12 months after discharge | up to one year |
| Evaluation of renal function | Measure of creatinine clearance at 3 and 12 months after discharge | up to one year |
| Evaluation of inflammation | Analysis for C-reactive protein at 3 and 12 months after discharge | up to one year |
| Evaluation of coagulation abnormality | Analysis for activated clotting time at 3 and 12 months | up to one year |
| Evaluation of quality of life in first year after discharge | Assessment of the Short Form Health Survey (SF36) at 3 and 12 months after discharge | up to one year |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |