Echocardiographic Manifestation in Patients With Omicron Variant of COVID-19

NCT05379543 | Unknown

• 1 other identifier: EARLY-MYO COVID-19 II
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• 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

Study Arms (4)

ICU-Severely ill group

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)

Other: Echocardiography

ICU-Critically ill group

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

Other: Echocardiography

Mildly ill group

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

Other: Echocardiography

Healthy control group

Healthy volunteers, matched for gender and age, without any signs or evidence of COVID-19 infection

Other: Echocardiography

Interventions

Echocardiography OTHER

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.

Healthy control group; ICU-Critically ill group; ICU-Severely ill group; Mildly ill group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: half male and half female will be enrolled
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected from all participants and circulation levels of inflammatory and cardiac biomarkers, and blood cell counts will be measured.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jun Pu, MD,PhD

  RenJi Hospital

  STUDY DIRECTOR

Central Study Contacts

Jun Pu, MD, PhD

CONTACT

13817577592; pujun310@hotmail.com

Zhiguo Zou, MD,PhD

CONTACT

13524596108; zouzhiguo@renji.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 18, 2022
• Study Start: May 30, 2022
• Primary Completion: July 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

CN (1)