An observational study in Covid19 and Echocardiography, sponsored by RenJi Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by RenJi Hospital · Observational
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).
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 51 is below the median of 260 across 3,188 observational studies indexed under COVID-19.
Browse COVID-19 studies →RenJi Hospital is the lead sponsor of 550 studies on the registry; 248 are open to participants now.
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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
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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
Exclusion Criteria:
Patients who were \< 18 years and whose entire stay in hospital lasted for \< 48 hours.
Patients deceased during the study period
Other: Echocardiography
Patients survived during the study period
Other: Echocardiography
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
Death
Death of any cause
Time frame: From admission to April 8 2020 (cutoff day)
Ran from Jan 2020 to primary completion in Apr 2020, 2 months.
Of 1,625 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 2 months is below that.
Counting every sponsor, half of 1,750 studies reached it within 13 months; a quarter within 5 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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