Clinical trial NCT05379543: Echocardiographic Manifestation in Patients With Omicron Variant of COVID-19
Official title: Cardiac Structural and Functional Characteristics in Patients With Omicron Infection: a Dynamic Echocardiographic Study in Shanghai, China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Left atrial diameter (cm)
timeFrame: Day at the enrollment
measure: Left ventricular internal dimension at end-diastole (cm)
timeFrame: Day at the enrollment
measure: Interventricular septum thickness (mm)
timeFrame: Day at the enrollment
measure: Left ventricular ejection fraction (%)
timeFrame: Day at the enrollment
Secondary outcomes:
measure: In hospital all-cause mortality (%)
timeFrame: Day at the time of data cut-off
measure: The need of invasive mechanical ventilation (%)
timeFrame: Day at the time of data cut-off
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: RenJi Hospital
name: Jun Pu, MD,PhD
role: STUDY_DIRECTOR
References: