Covid19NCT04352842
Echocardiographic Manifestation in Patient With COVID-19 （EARLY-MYO COVID-19）
An observational study of Covid19 and Echocardiography, run by RenJi Hospital at 1 site in China.
Trial summary
The cardiovascular effects of coronavirus disease 2019 (COVID-19) are not yet fully known. We conducted a prospective and dynamic echocardiographic study to investigate the cardiac structural and functional changes in COVID-19 patients in intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Echocardiography
- What is being tested?
- Echocardiography
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2020to 8 Apr 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted in an intensive care unit (ICU) during February 22 to April 3, 2019 in a special hospital for COVID-19 patients in Wuhan, China
Who may be able to join
- Patients had been diagnosed of COVID-19 according to the criteria established by the WHO interim guidance and admitted to ICU because of severe or critical condition
Who cannot join
- Patients who were < 18 years and whose entire stay in hospital lasted for < 48 hours.
Trial locations and contacts
1 site in 1 country.
China1 site
Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Cardiac Structural and Functional Characteristics in COVID-19: A Dynamic Echocardiographic Study
The cardiovascular effects of coronavirus disease 2019 (COVID-19) are not yet fully known. We conducted a prospective and dynamic echocardiographic study to investigate the cardiac structural and functional changes in COVID-19 patients in intensive care unit (ICU).
Read the detailed description
The ongoing pandemic of coronavirus disease 2019 (COVID-19) caused by the newly discovered severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) has become a global health crisis, resulting in 3,435,894 confirmed infections and 239,604 deaths worldwide by 4 May 2020 1. Although acute respiratory syndrome is the main manifestation of the disease2, the understanding of the impact of the virus on other organs is of importance in terms of multiple organ dysfunction/failure that contributed to the increased mortality in patients with COVID-19.
With the increase of confirmed cases and the accumulation of clinical data, the cardiovascular manifestations caused by COVID-19 has raised concern3. Some studies have reported that a certain percentage of patients presented cardiac injury as indicated by elevated cardiac biomarkers such as high-sensitivity cardiac troponin-I (hs-cTnI) and brain natriuretic peptide (BNP) 2,4,5. Cardiac complications, including acute heart failure, cardiac rupture and even sudden cardiac arrest, has also been described in several case reports 6-8. However, autopsy studies failed to find the evidence of direct assaults by the virus in myocyte or apparent myocyte necrosis/apoptosis in the heart 9. Typical pathological finding reported was mononuclear inflammatory infiltration in the myocardial interstitium but no substantial damage in cardiomyocytes in the heart 10,11. Thus, a significant gap exists in our knowledge between the clinical investigation and postmortem findings. At present, the in vivo morphological and functional features of cardiac injury remain unknown.
We therefore performed a prospective and dynamic echocardiography study to investigate the cardiac structural and functional changes in patients with COVID-19 who were admitted to intensive care unit (ICU), and to compare the cardiac characteristics between deceased and survived patients.
- Conditions
- Covid19, Echocardiography
- Being tested
- Echocardiography
- Keywords
- COVID-19, Echocardiography, cardiac structure, cardiac function
- 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
An expert with 17-year professional experience performed all the echocardiography examinations using a GE LOGIQTM e portable color ultrasound diagnostic machine (GE Healthcare, WI, USA) that was specially used in the contaminated area. Two-dimensional and Doppler echocardiographic measurements were conducted following the recommendations of the American Society of Echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Non-survivors | Patients deceased during the study period Receives: Other: Echocardiography | |
| Survivors | Patients survived during the study period Receives: Other: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death of any cause
Measured: From admission to April 8 2020 (cutoff day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start21 Jan 2020
- Primary completion8 Apr 2020
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Pu, M.D, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352842
- Sponsor's protocol ID
- COVID19-Echocardiography
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Structural and Functional Characteristics in COVID-19: A Dynamic Echocardiographic Study
- ClinicalTrials.gov ID
- NCT04352842
- Acronym / sponsor ID
- COVID19-Echocardiography
- Conditions
- Covid19, Echocardiography
- Keywords
- COVID-19, Echocardiography, cardiac structure, cardiac function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 20 Apr 2020 (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 effects of coronavirus disease 2019 (COVID-19) are not yet fully known. We conducted a prospective and dynamic echocardiographic study to investigate the cardiac structural and functional changes in COVID-19 patients in intensive care unit (ICU).
Detailed description
The ongoing pandemic of coronavirus disease 2019 (COVID-19) caused by the newly discovered severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) has become a global health crisis, resulting in 3,435,894 confirmed infections and 239,604 deaths worldwide by 4 May 2020 1. Although acute respiratory syndrome is the main manifestation of the disease2, the understanding of the impact of the virus on other organs is of importance in terms of multiple organ dysfunction/failure that contributed to the increased mortality in patients with COVID-19.
With the increase of confirmed cases and the accumulation of clinical data, the cardiovascular manifestations caused by COVID-19 has raised concern3. Some studies have reported that a certain percentage of patients presented cardiac injury as indicated by elevated cardiac biomarkers such as high-sensitivity cardiac troponin-I (hs-cTnI) and brain natriuretic peptide (BNP) 2,4,5. Cardiac complications, including acute heart failure, cardiac rupture and even sudden cardiac arrest, has also been described in several case reports 6-8. However, autopsy studies failed to find the evidence of direct assaults by the virus in myocyte or apparent myocyte necrosis/apoptosis in the heart 9. Typical pathological finding reported was mononuclear inflammatory infiltration in the myocardial interstitium but no substantial damage in cardiomyocytes in the heart 10,11. Thus, a significant gap exists in our knowledge between the clinical investigation and postmortem findings. At present, the in vivo morphological and functional features of cardiac injury remain unknown.
We therefore performed a prospective and dynamic echocardiography study to investigate the cardiac structural and functional changes in patients with COVID-19 who were admitted to intensive care unit (ICU), and to compare the cardiac characteristics between deceased and survived patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-survivors | – | Other: EchocardiographyPatients deceased during the study period |
| Survivors | – | Other: EchocardiographyPatients survived during the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in an intensive care unit (ICU) during February 22 to April 3, 2019 in a special hospital for COVID-19 patients in Wuhan, China
Key inclusion criteria (1 listed)
- Patients had been diagnosed of COVID-19 according to the criteria established by the WHO interim guidance and admitted to ICU because of severe or critical condition
Key exclusion criteria (1 listed)
- Patients who were < 18 years and whose entire stay in hospital lasted for < 48 hours.
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 |
|---|---|---|
| EchocardiographyAn expert with 17-year professional experience performed all the echocardiography examinations using a GE LOGIQTM e portable color ultrasound diagnostic machine (GE Healthcare, WI, USA) that was specially used in the contaminated area. Two-dimensional and Doppler echocardiographic measurements were conducted following the recommendations of the American Society of Echocardiography | Other | Non-survivors, Survivors |
Primary outcome
Death
Time frame: From admission to April 8 2020 (cutoff day)
Death of any cause
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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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, M.D principal investigator
Renji Hospital, School of Medicine, Shanghai Jiaotong University
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 Covid19 and Echocardiography, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 May 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: From admission to April 8 2020 (cutoff day)). 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 19 May 2020.