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The cardiovascular scenario associated with omicron, the new variant of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19), remains unclear. We design this observational and prospective study to explore cardiac manifestations in patients with omicron infection by echocardiography.
COVID-19 affects the cardiovascular system, and the presence of cardiovascular disease (CAD) and risk factors is associated with worse clinical outcomes in infected patients. However, there is a paucity of information regarding the cardiovascular scenario associated with omicron, the new variant of SARS-CoV-2 that causes COVID-19. Thus, we expect to perform this study to explore the echocardiographic manifestations in patients admitted to the hospital with confirmed COVID-19 infection, during the current omicron wave in Shanghai, China.
According to published guidelines, with written consent from eligible patients, participants are grouped into the severely ill group, the critically ill group, the mildly ill group, and the healthy control group. The investigators will review medical records and document detailed sociodemographic characteristics for each participant. Circulating levels of cardiac biomarkers such as B-type natriuretic peptide (BNP) and cardiac troponin (cTnI), inflammatory biomarkers such as interleukin 6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP), and blood cell counts are measured in the hospital-based laboratory. To study the cardiac manifestations of the patients, echocardiography is performed using a GE Vingmed Ultrasound System (GE Healthcare, Horten, Norway), and morphological and functional parameters of the heart are measured. Clinical outcomes will be censored at the time of data cut-off, and patients after discharge will continue to be interviewed by telephone. Differences in cardiac manifestations and clinical outcomes between the groups are compared by proper statistical tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICU-Severely ill group | Patients requiring transfer to the intensive care unit (ICU), and presenting with severe symptoms (dyspnea, respiratory rate ≥30/min, blood oxygen saturation ≤93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, or lung infiltrates >50% within 24 to 48 hours) |
| |
| ICU-Critically ill group | Patients requiring transfer to the ICU, and presenting with respiratory failure, septic shock, multiple organ dysfunction, or failure) |
| |
| Mildly ill group | Patients presenting with fever, mild to moderate respiratory symptoms, and with or without imaging presentations of pneumonia |
| |
| Healthy control group | Healthy volunteers, matched for gender and age, without any signs or evidence of COVID-19 infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography | Other | Echocardiography is performed using a GE Vingmed Ultrasound System (GE Healthcare, Horten, Norway), by an experienced expert. Morphological and functional parameters of the heart are measured in a consistent manner. |
| Measure | Description | Time Frame |
|---|---|---|
| Left atrial diameter (cm) | Left atrial diameter (LAD) is a morphological parameter, which is measured by echocardiography to assess the size of left atrium. | Day at the enrollment |
| Left ventricular internal dimension at end-diastole (cm) | Left ventricular internal dimension at end-diastole (LVIDd) is a morphological parameter, which is measured by echocardiography to assess the size of left ventricle. | Day at the enrollment |
| Interventricular septum thickness (mm) | Interventricular septum thickness is a morphological parameter, which is measured by echocardiography to assess the presence of ventricular hypertrophy. | Day at the enrollment |
| Left ventricular ejection fraction (%) | Left ventricular ejection fraction (LVEF) is a functional parameter, which is measured by echocardiography to assess ventricular systolic function. | Day at the enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| In hospital all-cause mortality (%) | To study the clinical outcome in the groups, patients are followed to death or discharge following the echocardiography. The rate of all-cause mortality (death) is calculated as a percentage (%) for the mildly ill group, the severely ill group, and the critically ill group. | Day at the time of data cut-off |
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Inclusion Criteria:
Exclusion Criteria:
half male and half female will be enrolled
Patients admitted to the hospital with confirmed omicron infection, are subgrouped into the severely ill group, the critically ill group, and the mildly ill group. Healthy volunteers are also enrolled in the healthy control group.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Pu, MD, PhD | Contact | 13817577592 | pujun310@hotmail.com | |
| Zhiguo Zou, MD,PhD | Contact | 13524596108 | zouzhiguo@renji.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Pu, MD,PhD | RenJi Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Shanghai | 200127 | China |
We have not make a decision regarding this issue
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Blood samples will be collected from all participants and circulation levels of inflammatory and cardiac biomarkers, and blood cell counts will be measured.
| The need of invasive mechanical ventilation (%) | Since COVID-19 mainly damages the respiratory system, some severely ill and critically ill patients may need the treatment of invasive mechanical ventilation (IMV). The percentage (%) of patients in each group receiving IMV is calculated to assess the clinical consequence of omicron infection. | Day at the time of data cut-off |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |