Echocardiographic Manifestation in Patients With Omicron Variant of COVID-19

NCT ID: NCT05379543

Last Updated: 2022-05-18

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-30

Study Completion Date

2022-12-30

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type 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.

ICU-Critically ill group

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

Echocardiography

Intervention Type 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.

Mildly ill group

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

Echocardiography

Intervention Type 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

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

Echocardiography

Intervention Type 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.

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Pu, MD,PhD

Role: STUDY_DIRECTOR

RenJi Hospital

Locations

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Renji Hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Jun Pu, MD, PhD

Role: CONTACT

13817577592

Zhiguo Zou, MD,PhD

Role: CONTACT

13524596108

Facility Contacts

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Jun Pu, MD, PhD

Role: primary

86-13817577592

Zhiguo Zou, MD, PhD

Role: backup

86-13524596108

Other Identifiers

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EARLY-MYO COVID-19 II

Identifier Type: -

Identifier Source: org_study_id

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