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Completed

NCT Number: NCT04352842

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

echocardiography

Other

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

Primary outcomes

  1. Death

    Time frame: From admission to April 8 2020 (cutoff day)

    Death of any cause

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Cardiac Structural and Functional Characteristics in COVID-19: A Dynamic Echocardiographic Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2020
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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