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Completed

NCT Number: NCT05317962

COVID-19 Echo Study

Investigation of the cardiac manifestations of COVID-19 in patients admitted to hospital

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

London North West University Healthcare NHS Trust

Harrow, HA1 3UJ, United Kingdom

About this study

The COVID-19 disease (caused by SARS-CoV-2) predominantly affects the lungs causing a pneumonia which can become severe and lead to death via a severe inflammatory response in the lungs for which patients require admission to intensive care units (ICU) and artificial ventilation of their lungs. However, early reports from China have documented an element of injury to the heart present in up to 20% of patients. They have also documented patients who have died on ICU from heart injury rather than lung injury in COVID-19 positive patients. There are increasing numbers of reports of patients with COVID-19 having significant inflammation of the heart. What is not known is the prevalence of significant inflammation of the heart secondary to the SARS-CoV-2 and also what the significance of the injury to the heart shown in 20% of patients through blood tests really represents. That is to say is the injury significant to the outcome of the patient?

In order to investigate this, it is proposed to conduct a heart scan in COVID-19 positive patients in hospital to determine what form of heart injury is caused by the disease as well as determining it's prevalence and whether a heart scan helps in risk stratifying the patient in terms of outcome. If it is found that there is a significant amount of heart injury done by the SARS-CoV-2 and it can be determined this at an early stage with a heart scan it may be possible to start a more aggressive strategy for the patient's management in hospital to reduce the chance of death. Alternatively, if it is found that the incidence of heart injury is low and a heart scan makes no difference to the management of the patient, medical teams can be advised of this.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years old
  • Positive swab or serology for COVID-19
  • Referred for echocardiographic evaluation for clinical reasons
  • Willing and able to give assent

Exclusion criteria

  • Known hypersensitivity to perflutren or known excipients in LUMINITY

Treatment and study plan

Transthoracic Echocardiogram

Diagnostic Test

Abbreviated transthoracic echocardiogram

Primary outcomes

  1. Prevalence of cardiac abnormalities and relationship to admission to ICU

    Time frame: 6 weeks from start of admission

Secondary outcomes

  1. Prevalence of cardiac abnormalities and relationship to need for mechanical ventilation

    Time frame: 6 weeks from start of admission

  2. Prevalence of cardiac abnormalities and relationship to death or discharge

    Time frame: 6 weeks from start of admission

Sponsors and collaborators

Lead sponsor

London North West Healthcare NHS Trust

Other

Registry information

Official study title

Cardiac Manifestations of COVID-19 in Patients Admitted to Hospital

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2022
Registry last updated
Apr 8, 2022

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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