COVID-19 Echo Study

Completed

• Conditions: Covid-19; Cardiac Disease
• Interventions: Diagnostic Test: Transthoracic echocardiogram

• Registration Number: NCT05317962
• Lead Sponsor: London North West Healthcare NHS Trust

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.

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-05-12
• Study First Submitted: 2020-09-09
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Study First Submitted QC: 2022-04-07
• Last Update Submitted: 2022-04-07
• Study First Posted: 2022-04-08
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 positive patients admitted to hospital	Transthoracic echocardiogram	-

Primary Outcome Measures

Name	Time	Method
Prevalence of cardiac abnormalities and relationship to admission to ICU	6 weeks from start of admission

Secondary Outcome Measures

Name	Time	Method
Prevalence of cardiac abnormalities and relationship to need for mechanical ventilation	6 weeks from start of admission
Prevalence of cardiac abnormalities and relationship to death or discharge	6 weeks from start of admission

Trial Locations

Locations (1)

London North West University Healthcare NHS Trust; 🇬🇧 Harrow, United Kingdom