COVID-19NCT05379543
Echocardiographic Manifestation in Patients With Omicron Variant of COVID-19
An observational study of COVID-19, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Echocardiography
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- People under the age of 18 years old
- Inability to lie or maintain posture during the echocardiographic examination
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital
Shanghai, 200127
Jun Pu, MD, PhD, 86-13817577592, pujun310@hotmail.com
Zhiguo Zou, MD, PhD, 86-13524596108, zouzhiguo@renji.com
About this study
Official title: Cardiac Structural and Functional Characteristics in Patients With Omicron Infection: a Dynamic Echocardiographic Study in Shanghai, China
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Echocardiography
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Echocardiography | |
| ICU-Critically ill group | Patients requiring transfer to the ICU, and presenting with respiratory failure, septic shock, multiple organ dysfunction, or failure) Receives: Other: Echocardiography | |
| Mildly ill group | Patients presenting with fever, mild to moderate respiratory symptoms, and with or without imaging presentations of pneumonia Receives: Other: Echocardiography | |
| Healthy control group | Healthy volunteers, matched for gender and age, without any signs or evidence of COVID-19 infection Receives: Other: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left atrial diameter (cm)
Left atrial diameter (LAD) is a morphological parameter, which is measured by echocardiography to assess the size of left atrium.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day at the enrollment
Secondary outcomes (2)
In hospital all-cause mortality (%)
To study the clinical outcome in the groups, patients are followed to death or discharge following the echocardiography. The rate of all-cause mortality (death) is calculated as a percentage (%) for the mildly ill group, the severely ill group, and the critically ill group.
Measured: Day at the time of data cut-off
The need of invasive mechanical ventilation (%)
Since COVID-19 mainly damages the respiratory system, some severely ill and critically ill patients may need the treatment of invasive mechanical ventilation (IMV). The percentage (%) of patients in each group receiving IMV is calculated to assess the clinical consequence of omicron infection.
Measured: Day at the time of data cut-off
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start30 May 2022 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Pu, MD,PhD, Study director, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379543
- Sponsor's protocol ID
- EARLY-MYO COVID-19 II
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not make a decision regarding this issue
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Structural and Functional Characteristics in Patients With Omicron Infection: a Dynamic Echocardiographic Study in Shanghai, China
- ClinicalTrials.gov ID
- NCT05379543
- Acronym / sponsor ID
- EARLY-MYO COVID-19 II
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 30 May 2022 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICU-Severely ill group | – | Other: EchocardiographyPatients 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) |
| ICU-Critically ill group | – | Other: EchocardiographyPatients requiring transfer to the ICU, and presenting with respiratory failure, septic shock, multiple organ dysfunction, or failure) |
| Mildly ill group | – | Other: EchocardiographyPatients presenting with fever, mild to moderate respiratory symptoms, and with or without imaging presentations of pneumonia |
| Healthy control group | – | Other: EchocardiographyHealthy volunteers, matched for gender and age, without any signs or evidence of COVID-19 infection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- People under the age of 18 years old
- Inability to lie or maintain posture during the echocardiographic examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyEchocardiography 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. | Other | Healthy control group, ICU-Critically ill group, ICU-Severely ill group, Mildly ill group |
Primary outcome
Left atrial diameter (cm)
Time frame: 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)
Time frame: 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)
Time frame: 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 (%)
Time frame: Day at the enrollment
Left ventricular ejection fraction (LVEF) is a functional parameter, which is measured by echocardiography to assess ventricular systolic function.
2 secondary outcomes
In hospital all-cause mortality (%)
Time frame: Day at the time of data cut-off
The need of invasive mechanical ventilation (%)
Time frame: Day at the time of data cut-off
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Undecided. We have not make a decision regarding this issue
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Pu, MD,PhD study director
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Pu, MD, PhD (13817577592, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left atrial diameter (cm) (time frame: Day at the enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.