COVID-19
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHEREchocardiography
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.
Sponsors
RenJi Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-75 years old * Half male and half female * Admitted to hospital with confirmed omicron infection * Able to receive an echocardiographic examination * Written informed consents * Healthy volunteers, matched for age and gender, are enrolled as the control group
Exclusion criteria
* People under the age of 18 years old * Inability to lie or maintain posture during the echocardiographic examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left atrial diameter (cm) | Day at the enrollment | Left atrial diameter (LAD) is a morphological parameter, which is measured by echocardiography to assess the size of left atrium. |
| Left ventricular internal dimension at end-diastole (cm) | Day at the enrollment | Left ventricular internal dimension at end-diastole (LVIDd) is a morphological parameter, which is measured by echocardiography to assess the size of left ventricle. |
| Interventricular septum thickness (mm) | Day at the enrollment | Interventricular septum thickness is a morphological parameter, which is measured by echocardiography to assess the presence of ventricular hypertrophy. |
| Left ventricular ejection fraction (%) | Day at the enrollment | Left ventricular ejection fraction (LVEF) is a functional parameter, which is measured by echocardiography to assess ventricular systolic function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In hospital all-cause mortality (%) | Day at the time of data cut-off | 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. |
| The need of invasive mechanical ventilation (%) | Day at the time of data cut-off | 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. |
Countries
China
Contacts
Primary ContactJun Pu, MD, PhD
Backup ContactZhiguo Zou, MD,PhD
Outcome results
None listed