Echocardiographic Manifestation in Patient With COVID-19 （EARLY-MYO COVID-19）

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).

Study Overview

• Status: Completed
• Conditions: Covid19; Echocardiography
• Intervention / Treatment: Other: Echocardiography

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 Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

Inclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-survivors; Patients deceased 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
Survivors; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death of any cause	From admission to April 8 2020 (cutoff day)

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Jun Pu, M.D, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 21, 2020
• Primary Completion (ACTUAL): April 8, 2020
• Study Completion (ACTUAL): April 8, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (ACTUAL): April 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Echocardiography; cardiac function; cardiac structure
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COVID19-Echocardiography

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No