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临床试验/NCT05379543
NCT05379543Unknown不适用

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

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年5月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Left atrial diameter (cm)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • People under the age of 18 years old
  • Inability to lie or maintain posture during the echocardiographic examination

结局指标

主要结局

Left atrial diameter (cm)

时间窗: 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)

时间窗: 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)

时间窗: 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 (%)

时间窗: Day at the enrollment

Left ventricular ejection fraction (LVEF) is a functional parameter, which is measured by echocardiography to assess ventricular systolic function.

次要结局

  • In hospital all-cause mortality (%)(Day at the time of data cut-off)
  • The need of invasive mechanical ventilation (%)(Day at the time of data cut-off)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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