Echocardiographic Manifestation in Patients With Omicron Variant of COVID-19
NCT ID: NCT05379543
Last Updated: 2022-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2022-05-30
2022-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
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.
ICU-Critically ill group
Patients requiring transfer to the ICU, and presenting with respiratory failure, septic shock, multiple organ dysfunction, or failure)
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.
Mildly ill group
Patients presenting with fever, mild to moderate respiratory symptoms, and with or without imaging presentations of pneumonia
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.
Healthy control group
Healthy volunteers, matched for gender and age, without any signs or evidence of COVID-19 infection
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Inability to lie or maintain posture during the echocardiographic examination
18 Years
75 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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Jun Pu, MD,PhD
Role: STUDY_DIRECTOR
RenJi Hospital
Locations
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Renji Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EARLY-MYO COVID-19 II
Identifier Type: -
Identifier Source: org_study_id
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