Echocardiographic Manifestation in Patients With Omicron Variant of COVID-19

COVID-19 Clinical Trial

Official title:

Cardiac Structural and Functional Characteristics in Patients With Omicron Infection: a Dynamic Echocardiographic Study in Shanghai, China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05379543
• Other study ID #: EARLY-MYO COVID-19 II
• Status: Not yet recruiting
• Start date: May 30, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2022
• Source: RenJi Hospital
• Contact: Jun Pu, MD, PhD
• Phone: 13817577592
• Email: pujun310[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Echocardiography
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.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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