Echocardiographic Manifestation in Patients With Omicron Variant of COVID-19

Shanghai Jiao Tong University

Status

Unknown

Conditions

COVID-19

Treatments

Other: Echocardiography

Study type

Observational

Funder types

Other

Identifiers

NCT05379543

EARLY-MYO COVID-19 II

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 4 patient groups

ICU-Severely ill group

Description:

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)

Treatment:

Other: Echocardiography

ICU-Critically ill group

Description:

Patients requiring transfer to the ICU, and presenting with respiratory failure, septic shock, multiple organ dysfunction, or failure)

Treatment:

Other: Echocardiography

Mildly ill group

Description:

Patients presenting with fever, mild to moderate respiratory symptoms, and with or without imaging presentations of pneumonia

Treatment:

Other: Echocardiography