Clinical trial NCT05317962: COVID-19 Echo Study
Official title: Cardiac Manifestations of COVID-19 in Patients Admitted to Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Cardiac Disease
Keywords: Echocardiography
Lead sponsor: London North West Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the cardiology department at Northwick Park Hospital to have a transthoracic echocardiogram who have also tested positive for COVID-19,

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old
2. Positive swab or serology for COVID-19
3. Referred for echocardiographic evaluation for clinical reasons
4. Willing and able to give assent

Exclusion Criteria:

1. Known hypersensitivity to perflutren or known excipients in LUMINITY

Primary outcomes:
measure: Prevalence of cardiac abnormalities and relationship to admission to ICU
timeFrame: 6 weeks from start of admission
Secondary outcomes:
measure: Prevalence of cardiac abnormalities and relationship to need for mechanical ventilation
timeFrame: 6 weeks from start of admission
measure: Prevalence of cardiac abnormalities and relationship to death or discharge
timeFrame: 6 weeks from start of admission
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: London North West University Healthcare NHS Trust
Study officials:
affiliation: North West London University Healthcare NHS Trust
name: Prof Roxy Senior, MD
role: PRINCIPAL_INVESTIGATOR
References: